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Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care

This study has been completed.
Sponsor:
Collaborator:
Society of Critical Care Medicine
Information provided by (Responsible Party):
Sandra K. Hanneman, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00542321
First received: October 9, 2007
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: October 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pneumonia, Ventilator Associated
Interventions: Other: Manual turn
Device: kinetic therapy bed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable. All enrolled patients assigned to group.

Reporting Groups
  Description
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
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

Participant Flow:   Overall Study
    Kinetic Therapy Bed     Manual Turn  
STARTED     8     8  
COMPLETED     8     7  
NOT COMPLETED     0     1  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
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
Total Total of all reporting groups

Baseline Measures
    Kinetic Therapy Bed     Manual Turn     Total  
Number of Participants  
[units: participants]
  8     8     16  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 11.4     54.3  ± 12.2     56.3  ± 11.5  
Gender  
[units: participants]
     
Female     4     5     9  
Male     4     3     7  
Ethnicity (NIH/OMB)  
[units: Participant]
     
Hispanic or Latino     1     3     4  
Not Hispanic or Latino     7     5     12  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participant]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     1     1     2  
White     6     7     13  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Vasopressor Use [1]
[units: Participant]
     
Presence     3     3     6  
Absence     5     5     10  
COPD Diagnosis [2]
[units: Participant]
     
Yes     0     4     4  
No     8     4     12  
Surgery  
[units: Participant]
     
Yes     3     2     5  
No     5     6     11  
APACHE II [3]
[units: Scores on a scale]
Mean ± Standard Deviation
  24  ± 5     27  ± 9     25  ± 6.7  
FIO2 [4]
[units: Fraction]
Mean ± Standard Deviation
  0.73  ± 0.25     0.77  ± 0.28     0.75  ± 0.26  
[1] Use of continuous intravenous infusion of any vasopressor during study period
[2] Diagnosis of chronic obstructive pulmonary disease (COPD) in medical record
[3] Score on the Acute Physiology and Chronic Health Evaluation (APACHE) II (acuity of illness)instrument. Score ranges from 0 to 71, with higher score indicating greater severity of illness and risk for mortality.
[4] Fraction of inspired oxygen (FIO2) from APACHE II assessment (highest FIO2 within 24 hours of ICU admission)



  Outcome Measures
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1.  Primary:   Incidence of Pulmonary Complications.   [ Time Frame: Participants were followed for the duration of ICU stay, an average of 10 days. ]

2.  Secondary:   Mechanical Ventilation Duration.   [ Time Frame: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days. ]

3.  Secondary:   ICU Length of Stay.   [ Time Frame: Participants were followed for the duration of ICU stay, an average of 10 days. ]

4.  Secondary:   ICU All-cause Mortality.   [ Time Frame: Participants were followed for the duration of ICU stay, an average of 10 days. ]

5.  Secondary:   Turning-related Events   [ Time Frame: Participants were followed for the duration of time on protocol, an average of 3.5 days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Reliance on chest X-ray interpretation only for detection of preventable pulmonary complications; small pilot study; kinetic therapy bed turn angle was less than 45 degrees


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sandra K. Hanneman, PhD, RN, FAAN
Organization: University of Texas Health Science Center at Houston
phone: 713-500-2030
e-mail: Sandra.K.Hanneman@uth.tmc.edu


Publications:

Responsible Party: Sandra K. Hanneman, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00542321     History of Changes
Other Study ID Numbers: TMCSCCMAACN
Study First Received: October 9, 2007
Results First Received: October 2, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board