An interventional study of Educational Intervention UKRC 1997 and Educational Intervention UKRC 2010 in Coma, sponsored by University of Oxford. Completed at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by University of Oxford · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
Randomized to standard care (control group) - observations only
Randomized to modified UKRC 1997 - Intervention and Observations
Other: Educational Intervention UKRC 1997
Randomized to modified UKRC 2010 - Intervention and Observations
Other: Educational Intervention UKRC 2010
Educational poster intervention indicating the modified UKRC 1997 recovery position
Educational poster intervention indicating the modified UKRC 2010 recovery position
Composite of aspiration pneumonitis or pneumonia
Time frame: 48 hours after GCS13
Proportion of patients developing hypoxia
Time frame: 48 hours after GCS13,
Development of pneumonia or pneumonitis, assessed individually
Time frame: 48 hours after GCS13
Mortality
Time frame: 7 days post discharge/last follow-up
Time to mortality
Time frame: 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
The number of documented episodes of hypoxia
Time frame: 48 hours after GCS 13
Percentage of observations in the recovery position
Time frame: whilst GCS<12, expected less than 2 months
Modified Rankin scale
Time frame: 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
Proportion of patients developing a pressure sore
Time frame: 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
Proportion of patients developing a new arm or leg peripheral nerve injury
Time frame: 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
Trends in Blood presure
measure Systolic and diastolic blood pressure levels
Time frame: during hospitalization, expected less than 2 months
Trends in heart rate
Time frame: 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
time to hypoxia
Time frame: 48 hours after GCS13, expected less than 2 months
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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