Critical Illness
Conditions
Keywords
Critical Illness, Physical rehabilitation
Brief summary
There is a need to know more about the safety of mobilizing intensive care unit (ICU) patients who are receiving vasoactive drugs that support the heart and blood pressure. But before this research can be done, several uncertainties need to be addressed. To answer these uncertainties, the investigators will ask ICU patients receiving vasoactive drugs to take part in a study in three main stages. Firstly ICU patients will be asked whether they would be happy to take part in a future research trial on the safety of mobilizing patients who are receiving vasoactive drugs. Secondly, data will be collected about the current mobilization on vasoactive drugs that occurs. Finally, the investigators will try to follow up these patients 60 days after they start the study, to carry out some questionnaires and a walking test with the patients. These tests may be used in future research to measure the effect of mobilizing patients on vasoactive drugs.
Detailed description
The current evidence is insufficient to accurately guide clinicians to know when it is safe to start mobilizing intensive care unit (ICU) patients receiving vasoactive drugs. Before a randomized controlled trial can be designed, several uncertainties need to be addressed. This includes clarifying what standard care is, what potential recruitment rates would be and what the most suitable primary outcome measure is. This study is an exploratory observational study which will aim to recruit up to 40 ICU patients receiving vasoactive drugs to further clarify standard care and to measure preliminary feasibility outcomes. Upon enrolment, patients and clinicians will be surveyed about the hypothetical acceptability of recruitment into a future randomized controlled trial. Then any routine mobilization that occurs whilst the patient is receiving vasoactive drugs will be analyzed, for example, to describe how clinicians assessed safety for mobilization. Finally, patient participants will be followed up at day 60 to assess the feasibility of measuring candidate primary outcome measures.
Interventions
OTHERMobilization
Physical rehabilitation
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient participants: Inclusion Criteria: * Patients admitted to the ICU who are receiving vasoactive drugs. * Age greater than or equal to 18 years old. * Expected to remain admitted to the ICU for at least 24 hours post-enrolment.
Exclusion criteria
* Any patient who is expected to die imminently, as per clinical opinion. * Any patient where mobilization is contraindicated by the nature of their existing injuries. * Where it is clear from the medical records that participants are prisoners or offenders on probation. * Patients with neuromuscular disease or acute brain injury or spinal cord injury. * If the patient and/or their consultee is unable to speak English. Clinicians participating in a survey on hypothetical randomization of patient participants: Inclusion criteria: * Clinicians who work in the intensive care unit where a patient participant has been admitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypothetical Recruitment Rate for a Future Randomised Controlled Trial. | Baseline (approximately one day from enrolment) | The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs. |
| Number of Participants With Follow-up at 60 Days | 60 days | Patient participant follow-up rate at 60 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable | Baseline (approximately one day from enrolment) | Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 3: protocolised rehabilitation versus standard care |
| Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed. | Baseline (approximately one day from enrolment) | Quantity of missing data resulting from measurement of participant pre-morbid co-morbidities. |
| Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed. | Baseline (approximately one day from enrolment) | Quantity of missing data resulting from measurement of participant pre-morbid frailty. |
| Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed. | Baseline (approximately one day from enrolment) | Quantity of missing data resulting from measurement of participant pre-morbid physical function. |
| Who Made the Final Decision Whether to Mobilize the Patient | Through duration of ICU stay (average of 7 days). | Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized. |
| The Reasons for the Decision When Patient Was Mobilized. | Through duration of ICU stay (average of 7 days). | Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized. Qualitative measure: reasons underwent content analysis, with the outcome being the themes summarizing the reasons. |
| Who Made the Final Decision Whether to Not Mobilize the Patient | Through duration of intensive care stay (average 7 days) | Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized. |
| The Reasons for the Decision When the Patient Was Not Mobilized. | Through duration of intensive care stay (average 7 days) | Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized. Qualitative variable: reasons underwent qualitative analysis, with the output of a list of themes summarizing the reasons. |
| The Reason Why a Mobilisation Treatment Was Stopped | Through duration of ICU stay (average of 7 days). | Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out. |
| Number of Serious Adverse Events | Through whole of study, an estimated 6 months | Number of serious adverse events |
| Number of ICU Physical Rehabilitation Adverse Events | Through duration of ICU stay (average of 7 days). | Recorded using ICU physical rehabilitation adverse event tool, both by treating clinician and by researcher case note review. |
| Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool. | Through duration of ICU stay (average of 7 days). | Adverse event tool is completed if a mobilisation treatment on vasoactive drugs is routinely carried out. |
| Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable | Baseline (approximately one day from enrolment) | Survey measuring participant acceptance of hypothetical randomisation scenarios: scenario 1: early versus no rehabilitation |
| Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Through second half of the study, an estimated 3 months | A survey measuring user opinion on whether an adverse event tool was for example understandable and an appropriate length using a scale with 'yes', 'no' or 'unsure' responses. Survey adapted from Hodgson, C., Needham, D., Haines, K., Bailey, M., Ward, A., Harrold, M., Young, P., Zanni, J., Buhr, H., Higgins, A., Presneill, J. & Berney, S. 2014. Feasibility and inter-rater reliability of the ICU mobility scale. Heart Lung, 43. |
| Time to First Mobilisation Treatment | Through duration of hospital stay (average of 22 days) | Number of days to first rehabilitation treatment |
| Time to First Being Able to Sit Out of Bed. | Through duration of hospital stay (average of 22 days) | Regardless of the assistance required. |
| Time to First Being Able to Stand. | Through duration of hospital stay (average of 22 days). | Regardless of the assistance required. |
| Time to First Being Able to Walk. | Through duration of hospital stay (average of 22 days). | Regardless of assistance required. |
| Intensive Care Unit Length of Stay. | From admission to ICU discharge (an average of 7 days) | — |
| Hospital Length of Stay | From admission to hospital discharge (average of 22 days) | — |
| Intensive Care Unit Mobility Scale Level at ICU Discharge. | ICU discharge (an average of 7 days from ICU admission) | Intensive care unit mobility scale records a patient's mobility level from 0 to 10, where 0 means no mobility and 10 means walking without assistance from people or a physical aid. |
| Number of Patient Participants Where All Candidate Primary Outcomes Are Completed. | 60 days. | Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test. |
| The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. | 60 days. | Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test. |
| Data to Inform a Future Sample Size for a Future Randomized Controlled Trial. | 60 days. | Measures of central tendency and variability of data for candidate outcome measures to inform a sample size for future randomised controlled trial, e.g. physical functioning measured by the physical function domain of the RAND 36-Item Health Survey 1.0 Questionnaire (RAND SF-36 v1), scores range from 0-100, where a higher score means better physical functioning. |
| Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool. | Through duration of ICU stay (average of 7 days). | Tool completed both by treating clinician and by researcher case note review. Number of mobilization treatment sessions on vasoactive drugs where adverse event tool is complete. |
| Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable | Baseline (approximately one day from enrolment) | Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intensive Care Patients Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation | 40 |
| Intensive Care Clinicians Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. | 50 |
| Intensive Care Rehabilitation Clinicians Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. | 10 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Intensive Care Patients | Intensive Care Clinicians | Intensive Care Rehabilitation Clinicians |
|---|---|---|---|---|
| Age, Continuous | 66 years | 66 years | — | — |
| APACHE (Acute physiology and chronic health evaluation)II score | 16 units on a scale | 16 units on a scale | — | — |
| BMI | 26 kg/m^2 | 26 kg/m^2 | — | — |
| Duration of invasive mechanical ventilation | 0 days | 0 days | — | — |
| Healthcare experience | 16 Years | — | 16 Years | — |
| Healthcare experience of rehabilitation clinicians | 9 Years STANDARD_DEVIATION 6 | — | — | 9 Years STANDARD_DEVIATION 6 |
| ICU experience | 11 Years | — | 11 Years | — |
| ICU experience of rehabilitation clinicians | 6 Years STANDARD_DEVIATION 5 | — | — | 6 Years STANDARD_DEVIATION 5 |
| Profession Doctor | 17 Participants | — | 17 Participants | 0 Participants |
| Profession Nurse | 26 Participants | — | 26 Participants | 0 Participants |
| Profession Physiotherapist | 17 Participants | — | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Black/African/Caribbean/Black British | 3 Participants | 3 Participants | — | — |
| Race/Ethnicity, Customized Ethnicity Other / not stated | 8 Participants | 8 Participants | — | — |
| Race/Ethnicity, Customized Ethnicity White | 29 Participants | 29 Participants | — | — |
| Region of Enrollment United Kingdom | 100 participants | 40 participants | 50 participants | 10 participants |
| Sequential Organ Failure Assessment (SOFA) score | 6 units on a scale | 6 units on a scale | — | — |
| Sex: Female, Male Female | 14 Participants | 14 Participants | — | — |
| Sex: Female, Male Male | 26 Participants | 26 Participants | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 40 | 0 / 50 | 0 / 10 |
| other Total, other adverse events | 0 / 40 | 0 / 50 | 0 / 10 |
| serious Total, serious adverse events | 0 / 40 | 0 / 50 | 0 / 10 |
Outcome results
Primary
Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.
The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.
Time frame: Baseline (approximately one day from enrolment)
Population: Number of participants without missing data for this outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Hypothetical Recruitment Rate for a Future Randomised Controlled Trial. | 30 Participants |
Primary
Number of Participants With Follow-up at 60 Days
Patient participant follow-up rate at 60 days.
Time frame: 60 days
Population: Total number of participants in this participant group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants With Follow-up at 60 Days | 40 Participants |
Secondary
Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.
Measures of central tendency and variability of data for candidate outcome measures to inform a sample size for future randomised controlled trial, e.g. physical functioning measured by the physical function domain of the RAND 36-Item Health Survey 1.0 Questionnaire (RAND SF-36 v1), scores range from 0-100, where a higher score means better physical functioning.
Time frame: 60 days.
Population: Number of participants with data available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Data to Inform a Future Sample Size for a Future Randomized Controlled Trial. | 20 Units on a scale |
Secondary
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
A survey measuring user opinion on whether an adverse event tool was for example understandable and an appropriate length using a scale with 'yes', 'no' or 'unsure' responses. Survey adapted from Hodgson, C., Needham, D., Haines, K., Bailey, M., Ward, A., Harrold, M., Young, P., Zanni, J., Buhr, H., Higgins, A., Presneill, J. & Berney, S. 2014. Feasibility and inter-rater reliability of the ICU mobility scale. Heart Lung, 43.
Time frame: Through second half of the study, an estimated 3 months
Population: Number of clinicians who completed the survey
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Clear, easy to understand? | 10 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Indicate its overall purpose? | 9 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Will people filling out the tool know how to? | 8 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Are the adverse events adequately defined? | 10 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Are the adverse events irrelevant or misleading? | 0 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Are the adverse events offensive or inappropriate? | 0 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Are adverse events unnecessary or repetitive? | 0 Participants |
| Intensive Care Patients | Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey. | Is the tool an appropriate length? | 10 Participants |
Secondary
Hospital Length of Stay
Time frame: From admission to hospital discharge (average of 22 days)
Population: Number of participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Hospital Length of Stay | 16 Days |
Secondary
Intensive Care Unit Length of Stay.
Time frame: From admission to ICU discharge (an average of 7 days)
Population: Number of participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Intensive Care Unit Length of Stay. | 7 Days |
Secondary
Intensive Care Unit Mobility Scale Level at ICU Discharge.
Intensive care unit mobility scale records a patient's mobility level from 0 to 10, where 0 means no mobility and 10 means walking without assistance from people or a physical aid.
Time frame: ICU discharge (an average of 7 days from ICU admission)
Population: Number of participants with data available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Intensive Care Unit Mobility Scale Level at ICU Discharge. | 5 Score on a scale |
Secondary
Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
Tool completed both by treating clinician and by researcher case note review. Number of mobilization treatment sessions on vasoactive drugs where adverse event tool is complete.
Time frame: Through duration of ICU stay (average of 7 days).
Population: Number of mobilization treatment sessions whilst receiving vasoactive drugs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool. | Completed by clinicians | 19 Treatments |
| Intensive Care Patients | Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool. | Completed by researcher | 41 Treatments |
Secondary
Number of ICU Physical Rehabilitation Adverse Events
Recorded using ICU physical rehabilitation adverse event tool, both by treating clinician and by researcher case note review.
Time frame: Through duration of ICU stay (average of 7 days).
Population: Number of treatment sessions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | Number of ICU Physical Rehabilitation Adverse Events | Measured by clinicians | 3 events |
| Intensive Care Patients | Number of ICU Physical Rehabilitation Adverse Events | Measured by researchers | 6 events |
Secondary
Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care
Time frame: Baseline (approximately one day from enrolment)
Population: For each of the 40 patient participants, number of randomization surveys completed by the four groups described above.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable | 25 Participants |
| Intensive Care Doctors | Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable | 30 Participants |
| Intensive Care Nurses | Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable | 28 Participants |
| Intensive Care Physiotherapists | Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable | 35 Participants |
Secondary
Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable
Survey measuring participant acceptance of hypothetical randomisation scenarios: scenario 1: early versus no rehabilitation
Time frame: Baseline (approximately one day from enrolment)
Population: For each of the 40 patient participants, number of randomisation surveys completed by the four groups described above.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable | 15 Participants |
| Intensive Care Doctors | Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable | 11 Participants |
| Intensive Care Nurses | Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable | 18 Participants |
| Intensive Care Physiotherapists | Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable | 6 Participants |
Secondary
Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 3: protocolised rehabilitation versus standard care
Time frame: Baseline (approximately one day from enrolment)
Population: For each of the 40 patient participants, number of randomisation surveys completed by the four groups described above.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable | 24 Participants |
| Intensive Care Doctors | Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable | 28 Participants |
| Intensive Care Nurses | Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable | 27 Participants |
| Intensive Care Physiotherapists | Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable | 33 Participants |
Secondary
Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid co-morbidities.
Time frame: Baseline (approximately one day from enrolment)
Population: Number of participants for whom pre-morbid evaluation of comorbidities was attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed. | 8 Participants |
Secondary
Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid frailty.
Time frame: Baseline (approximately one day from enrolment)
Population: Number of participants for whom pre-morbid evaluation of frailty was attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed. | 2 Participants |
Secondary
Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid physical function.
Time frame: Baseline (approximately one day from enrolment)
Population: Number of participants for whom the pre-morbid measurement of physical function was attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed. | 2 Participants |
Secondary
Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Time frame: 60 days.
Population: Number of participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Patients | Number of Patient Participants Where All Candidate Primary Outcomes Are Completed. | 6 Participants |
Secondary
Number of Serious Adverse Events
Number of serious adverse events
Time frame: Through whole of study, an estimated 6 months
Population: Number of mobilization treatment sessions for whom data was available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Care Patients | Number of Serious Adverse Events | 0 events |
Secondary
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Time frame: 60 days.
Population: Number of participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. | Mortality | 40 participants |
| Intensive Care Patients | The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. | Health-related quality of life | 16 participants |
| Intensive Care Patients | The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. | Disability | 15 participants |
| Intensive Care Patients | The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. | Physical functioning - patient reported | 15 participants |
| Intensive Care Patients | The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome. | Physical functioning - performance-based | 6 participants |
Secondary
The Reasons for the Decision When Patient Was Mobilized.
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized. Qualitative measure: reasons underwent content analysis, with the outcome being the themes summarizing the reasons.
Time frame: Through duration of ICU stay (average of 7 days).
Population: Number of mobilization treatments where data was available for analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | Vasoactive dose decreasing and blood pressure improved | 1 Entire group where data available |
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | Cardiovascularly stable and/or minimal vasoactive drug dose | 1 Entire group where data available |
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | Was cardiovascularly stable on initial cautious mobilisation. | 1 Entire group where data available |
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | Post-operative | 1 Entire group where data available |
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | Rationale for chest optimisation and improve strength and function. | 1 Entire group where data available |
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | To assess strength and alertness | 1 Entire group where data available |
| Intensive Care Patients | The Reasons for the Decision When Patient Was Mobilized. | Surgical wound safe to mobilise / medically stable | 1 Entire group where data available |
Secondary
The Reasons for the Decision When the Patient Was Not Mobilized.
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized. Qualitative variable: reasons underwent qualitative analysis, with the output of a list of themes summarizing the reasons.
Time frame: Through duration of intensive care stay (average 7 days)
Population: Number of reviews by a physiotherapist where patient was not mobilized and where data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Patient sedated / drowsy / confused | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Patient fatigue | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Patient too unwell | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Blood pressure low and/or increasing/high vasoactive drug dose | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Lack of staff | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Pain | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Did not give consent | 1 Whole group where data was available |
| Intensive Care Patients | The Reasons for the Decision When the Patient Was Not Mobilized. | Filter | 1 Whole group where data was available |
Secondary
The Reason Why a Mobilisation Treatment Was Stopped
Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out.
Time frame: Through duration of ICU stay (average of 7 days).
Population: Number of treatment sessions for whom data was available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | The Reason Why a Mobilisation Treatment Was Stopped | Aim of session achieved | 10 Treatments |
| Intensive Care Patients | The Reason Why a Mobilisation Treatment Was Stopped | Declined | 1 Treatments |
| Intensive Care Patients | The Reason Why a Mobilisation Treatment Was Stopped | Symptomatic hypotension | 2 Treatments |
| Intensive Care Patients | The Reason Why a Mobilisation Treatment Was Stopped | Patient weakness/fatigue | 6 Treatments |
| Intensive Care Patients | The Reason Why a Mobilisation Treatment Was Stopped | Pain/discomfort | 2 Treatments |
Secondary
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
Adverse event tool is completed if a mobilisation treatment on vasoactive drugs is routinely carried out.
Time frame: Through duration of ICU stay (average of 7 days).
Population: Number of mobilization treatments where adverse event tool used and data available for how long it took to complete.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool. | < 1 minute | 2 Treatments |
| Intensive Care Patients | Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool. | 1-3 minutes | 2 Treatments |
| Intensive Care Patients | Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool. | 5-10 minutes | 1 Treatments |
Secondary
Time to First Being Able to Sit Out of Bed.
Regardless of the assistance required.
Time frame: Through duration of hospital stay (average of 22 days)
Population: Number of patient participants with data available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Time to First Being Able to Sit Out of Bed. | 5 Days |
Secondary
Time to First Being Able to Stand.
Regardless of the assistance required.
Time frame: Through duration of hospital stay (average of 22 days).
Population: Number of participants with data available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Time to First Being Able to Stand. | 3 Days |
Secondary
Time to First Being Able to Walk.
Regardless of assistance required.
Time frame: Through duration of hospital stay (average of 22 days).
Population: Number of participants with data available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Time to First Being Able to Walk. | 8 Days |
Secondary
Time to First Mobilisation Treatment
Number of days to first rehabilitation treatment
Time frame: Through duration of hospital stay (average of 22 days)
Population: Number of participants with data available for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Patients | Time to First Mobilisation Treatment | 2 Days |
Secondary
Who Made the Final Decision Whether to Mobilize the Patient
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized.
Time frame: Through duration of ICU stay (average of 7 days).
Population: Number of mobilization treatments where data was available for analysis. Please note the categories presented below are not mutually exclusive e.g. a decision whether to mobilize could have been made with a nurse and a doctor. Therefore, the sum of the categories will be greater than the overall number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | Who Made the Final Decision Whether to Mobilize the Patient | Alone | 9 Treatment sessions |
| Intensive Care Patients | Who Made the Final Decision Whether to Mobilize the Patient | Nurse | 7 Treatment sessions |
| Intensive Care Patients | Who Made the Final Decision Whether to Mobilize the Patient | Lead physiotherapist | 3 Treatment sessions |
| Intensive Care Patients | Who Made the Final Decision Whether to Mobilize the Patient | Senior doctor | 1 Treatment sessions |
| Intensive Care Patients | Who Made the Final Decision Whether to Mobilize the Patient | Doctor in charge | 4 Treatment sessions |
| Intensive Care Patients | Who Made the Final Decision Whether to Mobilize the Patient | Surgical team | 1 Treatment sessions |
Secondary
Who Made the Final Decision Whether to Not Mobilize the Patient
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized.
Time frame: Through duration of intensive care stay (average 7 days)
Population: Number of reviews by a physiotherapist where patient was not mobilized and where data was available. i.e. the overall number of participants analyzed/denominator is actually the overall number of physiotherapist reviews. Please note the categories presented below are not mutually exclusive e.g. the decision not to mobilize could have been made with a nurse and a physiotherapist. Therefore, the sum of the categories exceeds with overall number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Care Patients | Who Made the Final Decision Whether to Not Mobilize the Patient | Alone | 20 Reviews |
| Intensive Care Patients | Who Made the Final Decision Whether to Not Mobilize the Patient | Lead physiotherapist | 6 Reviews |
| Intensive Care Patients | Who Made the Final Decision Whether to Not Mobilize the Patient | Nurse | 3 Reviews |