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Completed

NCT Number: NCT00542321

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

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.

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Key information

Conditions

Pneumonia, Ventilator Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual turn

Other

Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation

Other names: Lateral rotation

kinetic therapy bed

Device

Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation

Other names: CLRT (continuous lateral rotation therapy), KT (kinetic therapy)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mechanical Ventilation Duration.

    Time frame: 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

  2. ICU Length of Stay.

    Time frame: 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

  3. ICU All-cause Mortality.

    Time frame: 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

  4. Turning-related Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Society of Critical Care Medicine

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 11, 2007
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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