Clinical trial NCT02427633: Study of Body Positions in Unconsciousness
Official title: A Randomised Controlled Study of the Use of Recovery Positions for Comatose Patients in a Resource Limited Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coma
Keywords: recovery position
comatose
resource limited
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Chittagong Medical College and Hospital
First posted: 2015-04-28
Enrollment: 1540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of aspiration pneumonitis or pneumonia
timeFrame: 48 hours after GCS13
Secondary outcomes:
measure: Proportion of patients developing hypoxia
timeFrame: 48 hours after GCS13,
measure: Development of pneumonia or pneumonitis, assessed individually
timeFrame: 48 hours after GCS13
measure: Mortality
timeFrame: 7 days post discharge/last follow-up
measure: Time to mortality
timeFrame: 7 days post discharge/last follow-up
measure: Coma recovery time, defined as time to GCS 15
timeFrame: during hospitalization (defined as time to GCS 15), expected less than 4 weeks
measure: The number of documented episodes of hypoxia
timeFrame: 48 hours after GCS 13
measure: Percentage of observations in the recovery position
timeFrame: whilst GCS<12, expected less than 2 months
measure: Modified Rankin scale
timeFrame: on discharge, expected less than 2 months
measure: Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury
timeFrame: whilst GCS<12, expected less than 2 months
measure: Proportion of patients developing a pressure sore
timeFrame: whilst GCS<12, expected less than 2 months
measure: Proportion of patients developing a venous thrombosis,
timeFrame: whilst GCS<12, expected less than 2 months
measure: Proportion of patients developing a new arm or leg peripheral nerve injury
timeFrame: during hospitalization, expected less than 2 months
measure: Proportion of patients developing a new arm or leg joint injury
timeFrame: during hospitalization, expected less than 2 months
measure: Trends in Blood presure
timeFrame: during hospitalization, expected less than 2 months
measure: Trends in heart rate
timeFrame: during hospitalization, expected less than 2 months
measure: Proportion of patients developing peripheral venous cannula function
timeFrame: whilst GCS<12, expected less than 2 months
measure: time to hypoxia
timeFrame: 48 hours after GCS13, expected less than 2 months
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chittagong Medical College Hospital
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Hugh Kingston, Dr.
role: PRINCIPAL_INVESTIGATOR
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