Study of Body Positions in Unconsciousness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coma

Intervention / Treatment
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* Other: Educational Intervention UKRC 1997
* Other: Educational Intervention UKRC 2010


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of aspiration pneumonitis or pneumonia |  | 48 hours after GCS13 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recovery position, comatose, resource limited