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Completed

NCT Number: NCT02427633

Study of Body Positions in Unconsciousness

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.

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Key information

Conditions

Coma Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chittagong Medical College Hospital

Chittagong, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Educational Intervention UKRC 1997

Other

Educational poster intervention indicating the modified UKRC 1997 recovery position

Educational Intervention UKRC 2010

Other

Educational poster intervention indicating the modified UKRC 2010 recovery position

Primary outcomes

  1. Composite of aspiration pneumonitis or pneumonia

    Time frame: 48 hours after GCS13

Secondary outcomes

  1. Proportion of patients developing hypoxia

    Time frame: 48 hours after GCS13,

  2. Development of pneumonia or pneumonitis, assessed individually

    Time frame: 48 hours after GCS13

  3. Mortality

    Time frame: 7 days post discharge/last follow-up

  4. Time to mortality

    Time frame: 7 days post discharge/last follow-up

  5. Coma recovery time, defined as time to GCS 15

    Time frame: during hospitalization (defined as time to GCS 15), expected less than 4 weeks

  6. The number of documented episodes of hypoxia

    Time frame: 48 hours after GCS 13

  7. Percentage of observations in the recovery position

    Time frame: whilst GCS<12, expected less than 2 months

  8. Modified Rankin scale

    Time frame: on discharge, expected less than 2 months

  9. Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury

    Time frame: whilst GCS<12, expected less than 2 months

  10. Proportion of patients developing a pressure sore

    Time frame: whilst GCS<12, expected less than 2 months

  11. Proportion of patients developing a venous thrombosis,

    Time frame: whilst GCS<12, expected less than 2 months

  12. Proportion of patients developing a new arm or leg peripheral nerve injury

    Time frame: during hospitalization, expected less than 2 months

  13. Proportion of patients developing a new arm or leg joint injury

    Time frame: during hospitalization, expected less than 2 months

  14. Trends in Blood presure

    Time frame: during hospitalization, expected less than 2 months

    measure Systolic and diastolic blood pressure levels

  15. Trends in heart rate

    Time frame: during hospitalization, expected less than 2 months

  16. Proportion of patients developing peripheral venous cannula function

    Time frame: whilst GCS<12, expected less than 2 months

  17. time to hypoxia

    Time frame: 48 hours after GCS13, expected less than 2 months

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Chittagong Medical College and Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2015
Registry last updated
Oct 12, 2020

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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