Pneumonia, Ventilator Associated
Conditions
Keywords
lateral rotation, kinetic therapy, mechanical ventilation, pulmonary complications
Brief summary
Intensive care unit (ICU) patients on respirators are at high risk for preventable pulmonary complications (PPC). Turning these patients from side to side may reduce PPC, but carries the burden of decreases in blood pressure and oxygenation. The investigators hypothesize that there will be no difference in PPC or adverse events when ICU patients on respirators are turned by nurses or by an automated turning bed.
Detailed description
The purpose of this pilot study is to test the feasibility of two turning protocols and study procedures for a multi-site randomized clinical trial to evaluate efficacy and safety of horizontal positioning interventions to reduce pulmonary complications in mechanically ventilated critically ill adult patients. The hypothesis of the randomized controlled trial (RCT) is no difference in pulmonary complications between manual, 2-hourly lateral rotation to \> 45 degrees (control), and continuous automated turning to 45 degrees (experimental) groups.
Interventions
OTHERManual turn
Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
DEVICEkinetic therapy bed
Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation
Sponsors
Society of Critical Care Medicine
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* receiving mechanical ventilation * ability to place on study protocol within 8 hours of intubation
Exclusion criteria
* pulmonary mass, pneumothorax, hemothorax, pleural effusion, or other source of compression atelectasis at time of assessment for eligibility * systolic blood pressure \< 90 mmHg with vasopressor support * orthopedic injuries requiring limited or complete immobilization * head injury requiring intracranial pressure monitoring * unstable spinal injuries * rib fractures * body weight \> 350 lbs * intubation within the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pulmonary Complications. | Participants were followed for the duration of ICU stay, an average of 10 days. | Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation Duration. | Participants were followed for the duration of mechanical ventilation, an average of 5.5 days. | Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation |
| ICU Length of Stay. | Participants were followed for the duration of ICU stay, an average of 10 days. | Time in days from study ICU admission to study ICU discharge or death |
| ICU All-cause Mortality. | Participants were followed for the duration of ICU stay, an average of 10 days. | Death from any reason between admission and discharge from study ICU |
| Turning-related Events | Participants were followed for the duration of time on protocol, an average of 3.5 days. | Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group |
Participant flow
Recruitment details
Recruitment period spanned 8.6 months (between 09/28/07 - 04/30/07 and 05/01/09 - 08/31/09) and was done in 2 ICUs of 2 tertiary hospitals. Recruitment efforts were intermittent due to staffing resources and reconfiguration and testing of automated turn bed angle sensor.
Pre-assignment details
Not applicable. All enrolled patients assigned to group.
Participants by arm
| Arm | Count |
|---|---|
| Kinetic Therapy Bed Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days | 8 |
| Manual Turn Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Manual Turn | Total | Kinetic Therapy Bed |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 12.2 | 56.3 years STANDARD_DEVIATION 11.5 | 58 years STANDARD_DEVIATION 11.4 |
| APACHE II | 27 Scores on a scale STANDARD_DEVIATION 9 | 25 Scores on a scale STANDARD_DEVIATION 6.7 | 24 Scores on a scale STANDARD_DEVIATION 5 |
| COPD Diagnosis No | 4 Participant | 12 Participant | 8 Participant |
| COPD Diagnosis Yes | 4 Participant | 4 Participant | 0 Participant |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| FIO2 | 0.77 Fraction STANDARD_DEVIATION 0.28 | 0.75 Fraction STANDARD_DEVIATION 0.26 | 0.73 Fraction STANDARD_DEVIATION 0.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
| Surgery No | 6 Participant | 11 Participant | 5 Participant |
| Surgery Yes | 2 Participant | 5 Participant | 3 Participant |
| Vasopressor Use Absence | 5 Participant | 10 Participant | 5 Participant |
| Vasopressor Use Presence | 3 Participant | 6 Participant | 3 Participant |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 7 / 7 |
| serious Total, serious adverse events | 4 / 8 | 3 / 7 |
Outcome results
Primary
Incidence of Pulmonary Complications.
Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.
Time frame: Participants were followed for the duration of ICU stay, an average of 10 days.
Population: Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kinetic Therapy Bed | Incidence of Pulmonary Complications. | 1 participants |
| Manual Turn | Incidence of Pulmonary Complications. | 1 participants |
Comparison: Pearson Chi-Square Test for difference between groupsp-value: 1Fisher Exact
Secondary
ICU All-cause Mortality.
Death from any reason between admission and discharge from study ICU
Time frame: Participants were followed for the duration of ICU stay, an average of 10 days.
Population: All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kinetic Therapy Bed | ICU All-cause Mortality. | 2 participants |
| Manual Turn | ICU All-cause Mortality. | 2 participants |
p-value: 1Fisher Exact
Secondary
ICU Length of Stay.
Time in days from study ICU admission to study ICU discharge or death
Time frame: Participants were followed for the duration of ICU stay, an average of 10 days.
Population: All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Kinetic Therapy Bed | ICU Length of Stay. | 11.1 Days |
| Manual Turn | ICU Length of Stay. | 8.2 Days |
p-value: 0.451Wilcoxon (Mann-Whitney)
Secondary
Mechanical Ventilation Duration.
Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
Time frame: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.
Population: All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kinetic Therapy Bed | Mechanical Ventilation Duration. | 5.97 Days | Standard Deviation 4.99 |
| Manual Turn | Mechanical Ventilation Duration. | 5.21 Days | Standard Deviation 4.29 |
Comparison: There will be no difference in duration of mechanical ventilation between groups.p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Turning-related Events
Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group
Time frame: Participants were followed for the duration of time on protocol, an average of 3.5 days.
Population: All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kinetic Therapy Bed | Turning-related Events | 138 Events | Standard Deviation 131 |
| Manual Turn | Turning-related Events | 125 Events | Standard Deviation 87 |
p-value: 1Wilcoxon (Mann-Whitney)