Covid19, Critical Care, Postintensive Care Syndrome
Conditions
Keywords
Covid19, Critical care, Postintensive Care Syndrome, Rehabilitation, Follow-up
Brief summary
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Our aim is to determine the impact of the COVID-19 pandemic on the physical, mental, and cognitive health of survivors, the experience of their families and their treating healthcare professionals in the long-term. This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Health care professionals will be invited to discuss the challenges faced during the pandemic using semi-structured interviews.
Interventions
OTHERIntensive care unit stay during the COVID-19 pandemic
Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open \[close\] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study
Sponsors
Clinica Alemana de Santiago
Clinica Indisa
Clinica Bupa Santiago
Hospital del Salvador
Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman
Hospital San Pablo de Coquimbo
Hospital Metropolitano
Universidad del Desarrollo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years old) * Mechanically ventilated for at least 48 hours
Exclusion criteria
* Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid) * S5q \< 5 or CAM-ICU positive within 72 hours after ICU discharge * Patient who do not understand or speak Spanish * Patient unable to communicate verbally * Burn or severe trauma as admission diagnosis * Any neurological disorder (i.e. spinal cord injury, stroke and brain tumours) as admission diagnosis * Transferred to a non-participating study centre before ICU discharge assessment * Recent prolonged hospital stay (extended by more than 3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 6 months after the ICU discharge | The WHODAS 2.0 is a self-reported disability questionnaire based on the International Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, organised under six domains (cognition, mobility, self-care, getting along, life activities and participation). Each question must be answered based on the perceived difficulty for performing activities using a 5-point scale (none, mild, moderate, severe and extreme). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Frailty Scale | Within 72 hours from ICU discharge | The CFS evaluates specific domains including physical functioning, activities of daily living (ADL), instrumental ADL, assistance for personal care, comorbidities, and cognition to generate a frailty score using a 9-point scale ranging from 1 (very fit) to 9 (terminally ill). A score greater than 4 is considered fragile |
| Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength | Within 72 hours from ICU discharge | the MRC-SS consists of a standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion). All muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible /palpable contraction; 1 = visible / palpable contraction or no limb movement; 2 = limb movement, but not against gravity; 3 = movement against the gravity over nearly the entire range of motion; 4 = motion against gravity and resistance, subjectively adjusted for gender and age; 5 = normal force). The score goes from 0 (no strength) to a maximum score of 60 points, indicating normal peripheral strength. |
| Functional Status Score for the Intensive Care Unit (FSS-ICU) | Within 72 hours from ICU discharge | The FSS-ICU is a mobility instrument to score the level of physical assistance required when performing five functional activities: rolling, transfer from supine to sit, sitting at the edge of the bed, transfer from sitting to stand, and walking. Each activity is scored using a 7-point scale ranging from 0 (not able to perform) to 7 (complete independence). The resulting overall score ranges from 0 to 35 points, where a higher scores indicates better performance. |
| Montreal Cognitive Assessment-Blind (MoCA Blind) | 6 months after the ICU discharge | The MoCA blind is a cognitive screening tool designed to detect cognitive dysfunction in five areas: memory, attention, language, abstraction and orientation. Each domain is scored separately for a total score ranging from 0 to 22 points. A score equal to or greater than 18 points is considered normal cognition. |
| Impact of Events Scale-Revised (IES-R) | 6 months after the ICU discharge | The IES-R is an interviewer or self-administered questionnaire designed to measure the subjective distress caused by traumatic events that has been validated for critical illness survivors. It comprises 22 questions in three subscales: intrusion, avoidance, and hyperarousal. Questions are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The score goes from 0 to 88 points. Scores above 33 are indicative of post-traumatic stress symptoms. |
| European Quality of Life Health Questionnaire (EQ-5D-3L) | 6 months after the ICU discharge | The EQ-5D-3L is an interviewer or self-administered questionnaire of health status or health-related quality of life, including five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and global health state. Each domain is scored based on 3 levels of severity: no problems, some problems, and extreme problems. Each combination of answers can be translated into a utility score, where 0 is similar to being dead and 1 represents the best possible quality of life. The utility scores were obtained using the Chilean Social valuation of EQ-5D health states (DOI: http://dx.doi.org/10.1016/j.jval.2011.09.002) |
| Employment Status | 6 months after the ICU discharge | The employment status was evaluated using the following questions: What is your current employment status? What working hours do you have? and has your employment situation changed after your ICU stay? |
| Survival | 6 months after the ICU discharge | Number of patients who survived |
| Hospital Anxiety and Depression Scale (HADS) | 6 months after the ICU discharge | The HADS is an interviewer or self-administered questionnaire designed to identify anxiety and depressive symptoms in a wide variety of in-hospital patients, which requires between 2 and 5 minutes to be completed. The HADS has fourteen questions, seven for anxiety and seven for depressive symptoms. Each question is rated with a 4-point scale ranging from 0 (absence) to 3 (extreme presence), resulting in a sum score of 21 points per subscale. For each subscale, a score \>8 indicates suspected anxiety or depression, while a score \>11 indicates clinical symptoms of anxiety or depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cohort Retention Rate | Every month during one year | Number of patients who can be contacted and evaluated |
Countries
Chile
Participant flow
Recruitment details
October 20th, 2020 to April 12th, 2021
Pre-assignment details
Not recruited (n=152) * Declined to participate (n=18) * Unable to cooperate (n=40) * Lack of evaluator (n=94)
Participants by arm
| Arm | Count |
|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a high bed occupancy in the pandemic
Intensive care unit stay during the COVID-19 pandemic: Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open \[close\] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study | 149 |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a low bed occupancy in the pandemic
Intensive care unit stay during the COVID-19 pandemic: Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open \[close\] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study | 103 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 8 |
| Overall Study | Lost to Follow-up | 111 | 56 |
| Overall Study | Withdrawal by Subject | 7 | 2 |
Baseline characteristics
| Characteristic | Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 61 years | 57 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 48 Participants | 41 Participants | 89 Participants |
| Sex: Female, Male Male | 101 Participants | 62 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 149 | 8 / 103 |
| other Total, other adverse events | 0 / 149 | 0 / 103 |
| serious Total, serious adverse events | 0 / 149 | 0 / 103 |
Outcome results
Primary
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
The WHODAS 2.0 is a self-reported disability questionnaire based on the International Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, organised under six domains (cognition, mobility, self-care, getting along, life activities and participation). Each question must be answered based on the perceived difficulty for performing activities using a 5-point scale (none, mild, moderate, severe and extreme). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability
Time frame: 6 months after the ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 5 units on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 13.5 units on a scale |
Secondary
Clinical Frailty Scale
The CFS evaluates specific domains including physical functioning, activities of daily living (ADL), instrumental ADL, assistance for personal care, comorbidities, and cognition to generate a frailty score using a 9-point scale ranging from 1 (very fit) to 9 (terminally ill). A score greater than 4 is considered fragile
Time frame: Within 72 hours from ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Clinical Frailty Scale | 2 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Clinical Frailty Scale | 3 score on a scale |
Secondary
Employment Status
The employment status was evaluated using the following questions: What is your current employment status? What working hours do you have? and has your employment situation changed after your ICU stay?
Time frame: 6 months after the ICU discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Employment Status | Employed-Part time | 3 Participants |
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Employment Status | Retired | 4 Participants |
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Employment Status | Umemployed | 4 Participants |
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Employment Status | No answer | 1 Participants |
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Employment Status | Employed-Full time | 18 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Employment Status | No answer | 0 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Employment Status | Employed-Full time | 17 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Employment Status | Employed-Part time | 3 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Employment Status | Umemployed | 9 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Employment Status | Retired | 8 Participants |
Secondary
European Quality of Life Health Questionnaire (EQ-5D-3L)
The EQ-5D-3L is an interviewer or self-administered questionnaire of health status or health-related quality of life, including five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and global health state. Each domain is scored based on 3 levels of severity: no problems, some problems, and extreme problems. Each combination of answers can be translated into a utility score, where 0 is similar to being dead and 1 represents the best possible quality of life. The utility scores were obtained using the Chilean Social valuation of EQ-5D health states (DOI: http://dx.doi.org/10.1016/j.jval.2011.09.002)
Time frame: 6 months after the ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | European Quality of Life Health Questionnaire (EQ-5D-3L) | 0.79 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | European Quality of Life Health Questionnaire (EQ-5D-3L) | 0.74 score on a scale |
Secondary
Functional Status Score for the Intensive Care Unit (FSS-ICU)
The FSS-ICU is a mobility instrument to score the level of physical assistance required when performing five functional activities: rolling, transfer from supine to sit, sitting at the edge of the bed, transfer from sitting to stand, and walking. Each activity is scored using a 7-point scale ranging from 0 (not able to perform) to 7 (complete independence). The resulting overall score ranges from 0 to 35 points, where a higher scores indicates better performance.
Time frame: Within 72 hours from ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Functional Status Score for the Intensive Care Unit (FSS-ICU) | 26 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Functional Status Score for the Intensive Care Unit (FSS-ICU) | 27 score on a scale |
Secondary
Hospital Anxiety and Depression Scale (HADS)
The HADS is an interviewer or self-administered questionnaire designed to identify anxiety and depressive symptoms in a wide variety of in-hospital patients, which requires between 2 and 5 minutes to be completed. The HADS has fourteen questions, seven for anxiety and seven for depressive symptoms. Each question is rated with a 4-point scale ranging from 0 (absence) to 3 (extreme presence), resulting in a sum score of 21 points per subscale. For each subscale, a score \>8 indicates suspected anxiety or depression, while a score \>11 indicates clinical symptoms of anxiety or depression.
Time frame: 6 months after the ICU discharge
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Hospital Anxiety and Depression Scale (HADS) | Depression subscale | 7 score on a scale |
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Hospital Anxiety and Depression Scale (HADS) | Anxiety subscale | 6 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Hospital Anxiety and Depression Scale (HADS) | Depression subscale | 7 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Hospital Anxiety and Depression Scale (HADS) | Anxiety subscale | 7 score on a scale |
Secondary
Impact of Events Scale-Revised (IES-R)
The IES-R is an interviewer or self-administered questionnaire designed to measure the subjective distress caused by traumatic events that has been validated for critical illness survivors. It comprises 22 questions in three subscales: intrusion, avoidance, and hyperarousal. Questions are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The score goes from 0 to 88 points. Scores above 33 are indicative of post-traumatic stress symptoms.
Time frame: 6 months after the ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Impact of Events Scale-Revised (IES-R) | 13.5 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Impact of Events Scale-Revised (IES-R) | 22 score on a scale |
Secondary
Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength
the MRC-SS consists of a standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion). All muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible /palpable contraction; 1 = visible / palpable contraction or no limb movement; 2 = limb movement, but not against gravity; 3 = movement against the gravity over nearly the entire range of motion; 4 = motion against gravity and resistance, subjectively adjusted for gender and age; 5 = normal force). The score goes from 0 (no strength) to a maximum score of 60 points, indicating normal peripheral strength.
Time frame: Within 72 hours from ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength | 52 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength | 50 score on a scale |
Secondary
Montreal Cognitive Assessment-Blind (MoCA Blind)
The MoCA blind is a cognitive screening tool designed to detect cognitive dysfunction in five areas: memory, attention, language, abstraction and orientation. Each domain is scored separately for a total score ranging from 0 to 22 points. A score equal to or greater than 18 points is considered normal cognition.
Time frame: 6 months after the ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Montreal Cognitive Assessment-Blind (MoCA Blind) | 21 score on a scale |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Montreal Cognitive Assessment-Blind (MoCA Blind) | 20 score on a scale |
Secondary
Survival
Number of patients who survived
Time frame: 6 months after the ICU discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Survival | 148 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Survival | 95 Participants |
Other Pre-specified
Cohort Retention Rate
Number of patients who can be contacted and evaluated
Time frame: Every month during one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic | Cohort Retention Rate | 30 Participants |
| Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic | Cohort Retention Rate | 37 Participants |