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Study of Body Positions in Unconsciousness

NCT02427633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1540

Last updated 2020-10-12

No results posted yet for this study

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.

Conditions

  • Coma

Interventions

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

Sponsors & Collaborators

  • Chittagong Medical College and Hospital

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Hugh Kingston, Dr. · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-23
Primary Completion
2020-03-21
Completion
2020-03-21

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427633 on ClinicalTrials.gov