NCT02427633

Study of Body Positions in Unconsciousness

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,540 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coma

Interventions

Type	Name	Description
OTHER	Educational Intervention UKRC 1997	Educational poster intervention indicating the modified UKRC 1997 recovery position
OTHER	Educational Intervention UKRC 2010	Educational poster intervention indicating the modified UKRC 2010 recovery position

Timeline

• Start date: 2014-08-23
• Primary completion: 2020-03-21
• Completion: 2020-03-21
• First posted: 2015-04-28
• Last updated: 2020-10-12

Locations

1 site across 1 country: Bangladesh