Pneumonia, Ventilator AssociatedNCT00542321

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

A study testing Manual turn and kinetic therapy bed in people with Pneumonia, Ventilator Associated, run by The University of Texas Health Science Center, Houston.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pneumonia, Ventilator Associated
What is being tested?: Manual turn and kinetic therapy bed
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: Sep 2007to Sep 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

receiving mechanical ventilation
ability to place on study protocol within 8 hours of intubation

Who cannot join

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

About this study

Official title: Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients

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.

Read the 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.

Conditions: Pneumonia, Ventilator Associated
Being tested: Manual turn, kinetic therapy bed
Keywords: lateral rotation, kinetic therapy, mechanical ventilation, pulmonary complications
Medical subject headings: Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual turnOther
Also called Lateral rotation
Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
kinetic therapy bedDevice
Also called CLRT (continuous lateral rotation therapy), KT (kinetic therapy)
Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation

Study groups in NCT00542321
Study group	Role	What they receive
Kinetic Therapy Bed	Experimental	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 Receives: Device: kinetic therapy bed
Manual Turn	Active comparator	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 Receives: Other: Manual turn

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Participants were followed for the duration of ICU stay, an average of 10 days.

Secondary outcomes (4)

Mechanical Ventilation Duration.
Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
Measured: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.
ICU Length of Stay.
Time in days from study ICU admission to study ICU discharge or death
Measured: Participants were followed for the duration of ICU stay, an average of 10 days.
ICU All-cause Mortality.
Death from any reason between admission and discharge from study ICU
Measured: Participants were followed for the duration of ICU stay, an average of 10 days.
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
Measured: Participants were followed for the duration of time on protocol, an average of 3.5 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Sep 2011

First posted11 Oct 2007 (estimated)
Study startSep 2007
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pneumonia, Ventilator AssociatedStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00542321
Sponsor's protocol ID: TMCSCCMAACN
Status last verified: Mar 2016
First submitted: 9 Oct 2007
Last updated: 6 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Padhye NS, Cron SG, Gusick GM, Hamlin SK, Hanneman SK. Randomization for clinical research: an easy-to-use spreadsheet method. Res Nurs Health. 2009 Oct;32(5):561-6. doi: 10.1002/nur.20341.
PubMed 19606450
Hamlin SK, Hanneman SK, Wachtel S, Gusick G. Adverse hemodynamic effects of lateral rotation during mechanical ventilation. Dimens Crit Care Nurs. 2008 Mar-Apr;27(2):54-61. doi: 10.1097/01.dcc.0000311593.87097.6a.
PubMed 18510182
Padhye NS, Hamlin S, Brazdeikis A, Hanneman SK. Cardiovascular impact of manual and automated turns in ICU. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1844-7. doi: 10.1109/IEMBS.2009.5332599.
PubMed 19963521
Hanneman SK, Gusick GM, Hamlin SK, Wachtel SJ, Cron SG, Jones DJ, Oldham SA. Manual vs automated lateral rotation to reduce preventable pulmonary complications in ventilator patients. Am J Crit Care. 2015 Jan;24(1):24-32. doi: 10.4037/ajcc2015171.
PubMed 25554551
Hamlin SK, Hanneman SK, Padhye NS, Lodato RF. Hemodynamic changes with manual and automated lateral turning in patients receiving mechanical ventilation. Am J Crit Care. 2015 Mar;24(2):131-40. doi: 10.4037/ajcc2015782.
PubMed 25727273

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pneumonia, Ventilator Associated trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients
ClinicalTrials.gov ID: NCT00542321
Acronym / sponsor ID: TMCSCCMAACN
Conditions: Pneumonia, Ventilator Associated
Keywords: lateral rotation, kinetic therapy, mechanical ventilation, pulmonary complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Society of Critical Care Medicine
Study start: Sep 2007
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 11 Oct 2007 (estimated)
Results: Posted 24 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Kinetic Therapy Bed	Experimental	Device: kinetic therapy bedKinetic 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	Active comparator	Other: Manual turnManual 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

receiving mechanical ventilation
ability to place on study protocol within 8 hours of intubation

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Manual turnAlso: Lateral rotationManual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation	Other	Manual Turn
kinetic therapy bedAlso: CLRT (continuous lateral rotation therapy), KT (kinetic therapy)Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation	Device	Kinetic Therapy Bed

Primary outcome

Incidence of Pulmonary Complications.
Time frame: 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.

4 secondary outcomes

Mechanical Ventilation Duration.
Time frame: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.
ICU Length of Stay.
Time frame: Participants were followed for the duration of ICU stay, an average of 10 days.
ICU All-cause Mortality.
Time frame: Participants were followed for the duration of ICU stay, an average of 10 days.
Turning-related Events
Time frame: Participants were followed for the duration of time on protocol, an average of 3.5 days.

Results and safety

Results posted to the registry on 24 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Kinetic Therapy Bed	8	8
Manual Turn	8	7

Primary outcome: Incidence of Pulmonary Complications.

Time frame: Participants were followed for the duration of ICU stay, an average of 10 days.. Number. Unit: participants

Measure	Kinetic Therapy Bed n = 8	Manual Turn n = 7
Value	1	1

Kinetic Therapy Bed vs Manual Turn: difference between proportions: .5, p = 1.00, Fisher Exact

Population analysed: 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)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time on protocol (7 days or less). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Kinetic Therapy Bed	4 of 8 (50%)	8 of 8 (100%)	Not reported
Manual Turn	3 of 7 (42.9%)	7 of 7 (100%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19606450Padhye NS, Cron SG, Gusick GM, Hamlin SK, Hanneman SK. Randomization for clinical research: an easy-to-use spreadsheet method. Res Nurs Health. 2009 Oct;32(5):561-6. doi: 10.1002/nur.20341.
Background: PubMed 18510182Hamlin SK, Hanneman SK, Wachtel S, Gusick G. Adverse hemodynamic effects of lateral rotation during mechanical ventilation. Dimens Crit Care Nurs. 2008 Mar-Apr;27(2):54-61. doi: 10.1097/01.dcc.0000311593.87097.6a.
Background: PubMed 19963521Padhye NS, Hamlin S, Brazdeikis A, Hanneman SK. Cardiovascular impact of manual and automated turns in ICU. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1844-7. doi: 10.1109/IEMBS.2009.5332599.
Background: PubMed 25554551Hanneman SK, Gusick GM, Hamlin SK, Wachtel SJ, Cron SG, Jones DJ, Oldham SA. Manual vs automated lateral rotation to reduce preventable pulmonary complications in ventilator patients. Am J Crit Care. 2015 Jan;24(1):24-32. doi: 10.4037/ajcc2015171.
Background: PubMed 25727273Hamlin SK, Hanneman SK, Padhye NS, Lodato RF. Hemodynamic changes with manual and automated lateral turning in patients receiving mechanical ventilation. Am J Crit Care. 2015 Mar;24(2):131-40. doi: 10.4037/ajcc2015782.

Related trials for Pneumonia, Ventilator Associated

Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
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Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra K. Hanneman, PhD, RN principal investigator

The University of Texas Health Science Center, Houston

Questions about this trial

What is this clinical trial studying?

A study testing Manual turn and kinetic therapy bed in people with Pneumonia, Ventilator Associated, run by The University of Texas Health Science Center, Houston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Pulmonary Complications. (time frame: Participants were followed for the duration of ICU stay, an average of 10 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00542321, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.