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NCT02427633
Study of Body Positions in Unconsciousness
NA trial testing Educational Intervention UKRC 1997 in Coma in 1,540 participants. Completed in 21 March 2020.
21 March 2020
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 1,540 |
| Start date | 23 August 2014 |
| Primary completion | 21 March 2020 |
| Estimated completion | 21 March 2020 |
| Sites | 1 location across Bangladesh |
Drugs / interventions tested
- Educational Intervention UKRC 1997
- Educational Intervention UKRC 2010
Conditions studied
- Coma — all drugs for Coma →
Sponsor
University of Oxford
Who can join
18 and older, any sex, with Coma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02427633
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Oxford trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02427633 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 12 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02427633.
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