Study of Body Positions in Unconsciousness

October 8, 2020 updated by: University of Oxford

A Randomised Controlled Study of the Use of Recovery Positions for Comatose Patients in a Resource Limited Setting

In resource limited settings, access to one-on-one nursing care and airway protection by intubation may be unavailable. Patients with coma but adequate oxygenation are frequently cared for on medical wards, and nursed by their family members. The investigators previously audited the use of the recovery position in patients with cerebral malaria and found that its usage was greatly increased by an educational intervention aimed at patient's caregivers. A trend to reduction in coma duration and aspiration pneumonia was also found. Since there is no evidence that placing comatose, non-intubated patients in a recovery position improves outcome, the investigators plan to conduct a randomised controlled study comparing standard care with an educational intervention targeting patients' relatives, teaching them to maintain their relative in one of two different recovery positions. With the preliminary efficacy and safety data and feedback that this study will provide, the investigators would then move to conduct a large multicenter study powered to detect a difference in mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods:

In this prospective, three-armed randomised controlled study, patients admitted to the adult medical wards of Chittagong Medical College Hospital with acute onset of reduced consciousness (Glasgow Coma Scale (GCS) <12 for less than 5 days) will be randomised 1:1:1 to one of three arms; standard care (no intervention) or an educational intervention directing placement into one of two recovery positions.

The educational intervention will occur following randomisation and on daily follow-up until recovery from deep coma or death. For patients in the intervention arms, the patients' relatives will be instructed on how to maintain their patient in the recovery position, and an educational poster will be attached to their bed.

Enrolled subjects will be observed 3 times a day until discharge for body position and vital signs including GCS, heart rate, respiratory rate and oxygen saturation.

The primary outcome will be the risk of (hazard ratio) aspiration pneumonia and pneumonitis. The secondary outcome measures will include time to hypoxia, death and coma recovery time. Pulmonary complications will be defined clinically and radiologically. The primary comparison between groups will be the standard care group versus both recovery positions combined. Analysis will be by intention to treat.

Study Type

Interventional

Enrollment (Actual)

1540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Chittagong, Bangladesh
        • Chittagong Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female admitted to the medical wards at CMCH
  • Current GCS < 12
  • Less than 5 day history of reduced consciousness
  • Written informed consent obtained through an adult (≥18 years) relative or parent/guardian

Exclusion Criteria:

  • Suspected head or spinal injury/trauma requiring appropriate immobilisation and stabilization
  • Patient physically restrained by ward staff due to agitation
  • Unsuitability for lateral positioning e.g. due to burns on lateral aspects, femoral vascular catheter
  • Requirement for nursing in an upright position e.g. due to respiratory insufficiency
  • Known or suspected pregnancy
  • Intubation
  • Patient or family member previously enrolled in this study.
  • Consent refused, or no adult (≥18 years) relative or parent/guardian present to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Randomized to standard care (control group) - observations only
Experimental: UKRC 1997
Randomized to modified UKRC 1997 - Intervention and Observations
Other: Educational Intervention UKRC 1997
Educational poster intervention indicating the modified UKRC 1997 recovery position
Experimental: UKRC 2010
Randomized to modified UKRC 2010 - Intervention and Observations
Other: Educational Intervention UKRC 2010
Educational poster intervention indicating the modified UKRC 2010 recovery position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of aspiration pneumonitis or pneumonia
Time Frame: 48 hours after GCS13
48 hours after GCS13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients developing hypoxia
Time Frame: 48 hours after GCS13,
48 hours after GCS13,
Development of pneumonia or pneumonitis, assessed individually
Time Frame: 48 hours after GCS13
48 hours after GCS13
Mortality
Time Frame: 7 days post discharge/last follow-up
7 days post discharge/last follow-up
Time to mortality
Time Frame: 7 days post discharge/last follow-up
7 days post discharge/last follow-up
Coma recovery time, defined as time to GCS 15
Time Frame: during hospitalization (defined as time to GCS 15), expected less than 4 weeks
during hospitalization (defined as time to GCS 15), expected less than 4 weeks
The number of documented episodes of hypoxia
Time Frame: 48 hours after GCS 13
48 hours after GCS 13
Percentage of observations in the recovery position
Time Frame: whilst GCS<12, expected less than 2 months
whilst GCS<12, expected less than 2 months
Modified Rankin scale
Time Frame: on discharge, expected less than 2 months
on discharge, expected less than 2 months
Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury
Time Frame: whilst GCS<12, expected less than 2 months
whilst GCS<12, expected less than 2 months
Proportion of patients developing a pressure sore
Time Frame: whilst GCS<12, expected less than 2 months
whilst GCS<12, expected less than 2 months
Proportion of patients developing a venous thrombosis,
Time Frame: whilst GCS<12, expected less than 2 months
whilst GCS<12, expected less than 2 months
Proportion of patients developing a new arm or leg peripheral nerve injury
Time Frame: during hospitalization, expected less than 2 months
during hospitalization, expected less than 2 months
Proportion of patients developing a new arm or leg joint injury
Time Frame: during hospitalization, expected less than 2 months
during hospitalization, expected less than 2 months
Trends in Blood presure
Time Frame: during hospitalization, expected less than 2 months
measure Systolic and diastolic blood pressure levels
during hospitalization, expected less than 2 months
Trends in heart rate
Time Frame: during hospitalization, expected less than 2 months
during hospitalization, expected less than 2 months
Proportion of patients developing peripheral venous cannula function
Time Frame: whilst GCS<12, expected less than 2 months
whilst GCS<12, expected less than 2 months
time to hypoxia
Time Frame: 48 hours after GCS13, expected less than 2 months
48 hours after GCS13, expected less than 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Chittagong Medical College and Hospital

Investigators

  • Principal Investigator: Hugh Kingston, Dr., Mahidol Oxford Tropical Medicine Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2014

Primary Completion (Actual)

March 21, 2020

Study Completion (Actual)

March 21, 2020

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BAKMAL1405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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