Study of Body Positions in Unconsciousness

NCT02427633 | Completed DMC

• 1 other identifier: BAKMAL1405
• Study Type: interventional
• Target: 1,540
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

recovery position; comatose; resource limited

Outcome Measures

Primary Outcomes (1)

• Composite of aspiration pneumonitis or pneumonia

  48 hours after GCS13

Secondary Outcomes (17)

• 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

Study Arms (3)

Control

NO INTERVENTION

Randomized to standard care (control group) - observations only

UKRC 1997

EXPERIMENTAL

Randomized to modified UKRC 1997 - Intervention and Observations

Other: Educational Intervention UKRC 1997

UKRC 2010

EXPERIMENTAL

Randomized to modified UKRC 2010 - Intervention and Observations

Other: Educational Intervention UKRC 2010

Interventions

Educational Intervention UKRC 1997 OTHER

Educational poster intervention indicating the modified UKRC 1997 recovery position

UKRC 1997

Educational Intervention UKRC 2010 OTHER

Educational poster intervention indicating the modified UKRC 2010 recovery position

UKRC 2010

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Chittagong Medical College and Hospital: collaborator

Study Sites (1)

Chittagong Medical College Hospital

Chittagong, Bangladesh

Location

Related Publications (25)

• Maude RJ, Hoque G, Hasan MU, Sayeed A, Akter S, Samad R, Alam B, Yunus EB, Rahman R, Rahman W, Chowdhury R, Seal T, Charunwatthana P, Chang CC, White NJ, Faiz MA, Day NP, Dondorp AM, Hossain A. Timing of enteral feeding in cerebral malaria in resource-poor settings: a randomized trial. PLoS One. 2011;6(11):e27273. doi: 10.1371/journal.pone.0027273. Epub 2011 Nov 16.

  PMID: 22110624 BACKGROUND

• Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castren M, Granja C, Handley AJ, Monsieurs KG, Perkins GD, Raffay V, Sandroni C. European Resuscitation Council Guidelines for Resuscitation 2010 Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2010 Oct;81(10):1277-92. doi: 10.1016/j.resuscitation.2010.08.009. No abstract available.

  PMID: 20956051 BACKGROUND

• Resuscitation Council (UK) Resuscitation 2010 Guidelines Edited by Jerry P. Nolan ISBN 978-1-903812-21-1

  BACKGROUND

• Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939.

  PMID: 20956221 BACKGROUND

• Leopold SJ, personal communication, November 2013.

  BACKGROUND

• Huxley EJ, Viroslav J, Gray WR, Pierce AK. Pharyngeal aspiration in normal adults and patients with depressed consciousness. Am J Med. 1978 Apr;64(4):564-8. doi: 10.1016/0002-9343(78)90574-0.

  PMID: 645722 BACKGROUND

• Adnet F, Baud F. Relation between Glasgow Coma Scale and aspiration pneumonia. Lancet. 1996 Jul 13;348(9020):123-4. doi: 10.1016/s0140-6736(05)64630-2. No abstract available.

  PMID: 8676684 BACKGROUND

• Markenson D, Ferguson JD, Chameides L, Cassan P, Chung KL, Epstein JL, Gonzales L, Hazinski MF, Herrington RA, Pellegrino JL, Ratcliff N, Singer AJ; First Aid Chapter Collaborators. Part 13: First aid: 2010 American Heart Association and American Red Cross International Consensus on First Aid Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S582-605. doi: 10.1161/CIRCULATIONAHA.110.971168. No abstract available.

  PMID: 20956261 BACKGROUND

• Adnet F, Borron SW, Finot MA, Minadeo J, Baud FJ. Relation of body position at the time of discovery with suspected aspiration pneumonia in poisoned comatose patients. Crit Care Med. 1999 Apr;27(4):745-8. doi: 10.1097/00003246-199904000-00028.

  PMID: 10321664 BACKGROUND

• Turner S, Turner I, Chapman D, Howard P, Champion P, Hatfield J, James A, Marshall S, Barber S. A comparative study of the 1992 and 1997 recovery positions for use in the UK. Resuscitation. 1998 Dec;39(3):153-60. doi: 10.1016/s0300-9572(98)00144-0.

  PMID: 10078804 BACKGROUND

• Fulstow R, Smith GB. The new recovery position, a cautionary tale. Resuscitation. 1993 Aug;26(1):89-91. doi: 10.1016/0300-9572(93)90167-o.

  PMID: 8210736 BACKGROUND

• Kumar P, Touquet R. Perils of the recovery position: neurapraxia of radial and common peroneal nerve. J Accid Emerg Med. 1996 Jan;13(1):69-70. doi: 10.1136/emj.13.1.69-c. No abstract available.

  PMID: 8821237 BACKGROUND

• Rathgeber J, Panzer W, Gunther U, Scholz M, Hoeft A, Bahr J, Kettler D. Influence of different types of recovery positions on perfusion indices of the forearm. Resuscitation. 1996 Jul;32(1):13-7. doi: 10.1016/0300-9572(96)00952-5.

  PMID: 8809913 BACKGROUND

• Doxey J. Comparing 1997 Resuscitation Council (UK) recovery position with recovery position of 1992 European Resuscitation Council guidelines: a user's perspective. Resuscitation. 1998 Dec;39(3):161-9. doi: 10.1016/s0300-9572(98)00142-7.

  PMID: 10078805 BACKGROUND

• The 1997 Resuscitation Guidelines for use in the United Kingdom April 1997. Resuscitation Council (UK) Publication.

  BACKGROUND

• Handley AJ, Becker LB, Allen M, van Drenth A, Kramer EB, Montgomery WH. Single rescuer adult basic life support. An advisory statement from the Basic Life Support Working Group of the International Liaison Committee on Resuscitation (ILCOR). Resuscitation. 1997 Apr;34(2):101-8. doi: 10.1016/s0300-9572(97)01099-x. No abstract available.

  PMID: 9141154 BACKGROUND

• Handley AJ. Resuscitation. Resuscitation Council (UK) wants everyone who uses new recovery position to report experiences. BMJ. 1997 Nov 15;315(7118):1308. No abstract available.

  PMID: 9390073 BACKGROUND

• Guidelines for the Treatment of Malaria. 2nd edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK254223/

  PMID: 25473692 BACKGROUND

• Bollig G, Wahl HA, Svendsen MV. Primary school children are able to perform basic life-saving first aid measures. Resuscitation. 2009 Jun;80(6):689-92. doi: 10.1016/j.resuscitation.2009.03.012. Epub 2009 Apr 21.

  PMID: 19386407 BACKGROUND

• Stroud M, Duncan H, Nightingale J; British Society of Gastroenterology. Guidelines for enteral feeding in adult hospital patients. Gut. 2003 Dec;52 Suppl 7(Suppl 7):vii1-vii12. doi: 10.1136/gut.52.suppl_7.vii1. No abstract available.

  PMID: 14612488 BACKGROUND

• Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.

  PMID: 8424572 BACKGROUND

• Sakai T, Planinsic RM, Quinlan JJ, Handley LJ, Kim TY, Hilmi IA. The incidence and outcome of perioperative pulmonary aspiration in a university hospital: a 4-year retrospective analysis. Anesth Analg. 2006 Oct;103(4):941-7. doi: 10.1213/01.ane.0000237296.57941.e7.

  PMID: 17000809 BACKGROUND

• Lim WS, Baudouin SV, George RC, Hill AT, Jamieson C, Le Jeune I, Macfarlane JT, Read RC, Roberts HJ, Levy ML, Wani M, Woodhead MA; Pneumonia Guidelines Committee of the BTS Standards of Care Committee. BTS guidelines for the management of community acquired pneumonia in adults: update 2009. Thorax. 2009 Oct;64 Suppl 3:iii1-55. doi: 10.1136/thx.2009.121434. No abstract available.

  PMID: 19783532 BACKGROUND

• Dalhoff K, Ewig S; Gideline Development Group; Abele-Horn M, Andreas S, Bauer TT, von Baum H, Deja M, Gastmeier P, Gatermann S, Gerlach H, Grabein B, Hoffken G, Kern W, Kramme E, Lange C, Lorenz J, Mayer K, Nachtigall I, Pletz M, Rohde G, Rosseau S, Schaaf B, Schaumann R, Schreiter D, Schutte H, Seifert H, Sitter H, Spies C, Welte T. Adult patients with nosocomial pneumonia: epidemiology, diagnosis, and treatment. Dtsch Arztebl Int. 2013 Sep;110(38):634-40. doi: 10.3238/arztebl.2013.0634. Epub 2013 Sep 20.

  PMID: 24133545 BACKGROUND

• American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.

  PMID: 15699079 BACKGROUND

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugh Kingston, Dr.

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: April 28, 2015
• Study Start: August 23, 2014
• Primary Completion: March 21, 2020
• Study Completion: March 21, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

BA (1)