Study of Body Positions in Unconsciousness
8 ottobre 2020 aggiornato da: University of Oxford
A Randomised Controlled Study of the Use of Recovery Positions for Comatose Patients in a Resource Limited Setting
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1540
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Chittagong, Bangladesh
- Chittagong Medical College Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Control
Randomized to standard care (control group) - observations only
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Sperimentale: UKRC 1997
Randomized to modified UKRC 1997 - Intervention and Observations
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Educational poster intervention indicating the modified UKRC 1997 recovery position
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Sperimentale: UKRC 2010
Randomized to modified UKRC 2010 - Intervention and Observations
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Educational poster intervention indicating the modified UKRC 2010 recovery position
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Composite of aspiration pneumonitis or pneumonia
Lasso di tempo: 48 hours after GCS13
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48 hours after GCS13
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of patients developing hypoxia
Lasso di tempo: 48 hours after GCS13,
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48 hours after GCS13,
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Development of pneumonia or pneumonitis, assessed individually
Lasso di tempo: 48 hours after GCS13
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48 hours after GCS13
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Mortality
Lasso di tempo: 7 days post discharge/last follow-up
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7 days post discharge/last follow-up
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Time to mortality
Lasso di tempo: 7 days post discharge/last follow-up
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7 days post discharge/last follow-up
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Coma recovery time, defined as time to GCS 15
Lasso di tempo: during hospitalization (defined as time to GCS 15), expected less than 4 weeks
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during hospitalization (defined as time to GCS 15), expected less than 4 weeks
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The number of documented episodes of hypoxia
Lasso di tempo: 48 hours after GCS 13
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48 hours after GCS 13
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Percentage of observations in the recovery position
Lasso di tempo: whilst GCS<12, expected less than 2 months
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whilst GCS<12, expected less than 2 months
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Modified Rankin scale
Lasso di tempo: on discharge, expected less than 2 months
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on discharge, expected less than 2 months
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Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury
Lasso di tempo: whilst GCS<12, expected less than 2 months
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whilst GCS<12, expected less than 2 months
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Proportion of patients developing a pressure sore
Lasso di tempo: whilst GCS<12, expected less than 2 months
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whilst GCS<12, expected less than 2 months
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Proportion of patients developing a venous thrombosis,
Lasso di tempo: whilst GCS<12, expected less than 2 months
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whilst GCS<12, expected less than 2 months
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Proportion of patients developing a new arm or leg peripheral nerve injury
Lasso di tempo: during hospitalization, expected less than 2 months
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during hospitalization, expected less than 2 months
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Proportion of patients developing a new arm or leg joint injury
Lasso di tempo: during hospitalization, expected less than 2 months
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during hospitalization, expected less than 2 months
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Trends in Blood presure
Lasso di tempo: during hospitalization, expected less than 2 months
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measure Systolic and diastolic blood pressure levels
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during hospitalization, expected less than 2 months
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Trends in heart rate
Lasso di tempo: during hospitalization, expected less than 2 months
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during hospitalization, expected less than 2 months
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Proportion of patients developing peripheral venous cannula function
Lasso di tempo: whilst GCS<12, expected less than 2 months
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whilst GCS<12, expected less than 2 months
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time to hypoxia
Lasso di tempo: 48 hours after GCS13, expected less than 2 months
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48 hours after GCS13, expected less than 2 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Hugh Kingston, Dr., Mahidol Oxford Tropical Medicine Research Unit
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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. Erratum In: Circulation. 2011 Oct 11;124(15):e402.
- 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.
- 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.
- 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.
- Resuscitation Council (UK) Resuscitation 2010 Guidelines Edited by Jerry P. Nolan ISBN 978-1-903812-21-1
- Leopold SJ, personal communication, November 2013.
- 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.
- 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.
- 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. Erratum In: Circulation. 2010 Nov 23;122(21):2227. Circulation. 2012 Apr 17;125(15):585.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- The 1997 Resuscitation Guidelines for use in the United Kingdom April 1997. Resuscitation Council (UK) Publication.
- 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.
- 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.
- Guidelines for the Treatment of Malaria. 2nd edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK254223/
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
23 agosto 2014
Completamento primario (Effettivo)
21 marzo 2020
Completamento dello studio (Effettivo)
21 marzo 2020
Date di iscrizione allo studio
Primo inviato
12 gennaio 2015
Primo inviato che soddisfa i criteri di controllo qualità
27 aprile 2015
Primo Inserito (Stima)
28 aprile 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 ottobre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- BAKMAL1405
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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