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Study of Body Positions in Unconsciousness

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ClinicalTrials.gov Identifier: NCT02427633
Recruitment Status : Recruiting
First Posted : April 28, 2015
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Chittagong Medical College and Hospital
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Coma Other: Educational Intervention UKRC 1997 Other: Educational Intervention UKRC 2010 Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Study of the Use of Recovery Positions for Comatose Patients in a Resource Limited Setting
Actual Study Start Date : August 23, 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

Arm Intervention/treatment
No Intervention: Control
Randomized to standard care (control group) - observations only
Experimental: UKRC 1997
Randomized to modified UKRC 1997 - Intervention and Observations
Other: Educational Intervention UKRC 1997
Educational poster intervention indicating the modified UKRC 1997 recovery position

Experimental: UKRC 2010
Randomized to modified UKRC 2010 - Intervention and Observations
Other: Educational Intervention UKRC 2010
Educational poster intervention indicating the modified UKRC 2010 recovery position




Primary Outcome Measures :
  1. Composite of aspiration pneumonitis or pneumonia [ Time Frame: 48 hours after GCS13 ]

Secondary Outcome Measures :
  1. Proportion of patients developing hypoxia [ Time Frame: 48 hours after GCS13, ]
  2. Development of pneumonia or pneumonitis, assessed individually [ Time Frame: 48 hours after GCS13 ]
  3. Mortality [ Time Frame: 7 days post discharge/last follow-up ]
  4. Time to mortality [ Time Frame: 7 days post discharge/last follow-up ]
  5. Coma recovery time, defined as time to GCS 15 [ Time Frame: during hospitalization (defined as time to GCS 15), expected less than 4 weeks ]
  6. The number of documented episodes of hypoxia [ Time Frame: 48 hours after GCS 13 ]
  7. Percentage of observations in the recovery position [ Time Frame: whilst GCS<12, expected less than 2 months ]
  8. Modified Rankin scale [ Time Frame: on discharge, expected less than 2 months ]
  9. Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury [ Time Frame: whilst GCS<12, expected less than 2 months ]
  10. Proportion of patients developing a pressure sore [ Time Frame: whilst GCS<12, expected less than 2 months ]
  11. Proportion of patients developing a venous thrombosis, [ Time Frame: whilst GCS<12, expected less than 2 months ]
  12. Proportion of patients developing a new arm or leg peripheral nerve injury [ Time Frame: during hospitalization, expected less than 2 months ]
  13. Proportion of patients developing a new arm or leg joint injury [ Time Frame: during hospitalization, expected less than 2 months ]
  14. Trends in Blood presure [ Time Frame: during hospitalization, expected less than 2 months ]
    measure Systolic and diastolic blood pressure levels

  15. Trends in heart rate [ Time Frame: during hospitalization, expected less than 2 months ]
  16. Proportion of patients developing peripheral venous cannula function [ Time Frame: whilst GCS<12, expected less than 2 months ]
  17. time to hypoxia [ Time Frame: 48 hours after GCS13, expected less than 2 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427633


Contacts
Contact: Stije Leopold, Dr. stije@tropmedres.ac
Contact: Hugh Kingston, Dr hugh@tropmedres.ac

Locations
Bangladesh
Chittagong Medical College Hospital Recruiting
Chittagong, Bangladesh
Contact: Saumitra Barua, Dr         
Sponsors and Collaborators
University of Oxford
Chittagong Medical College and Hospital
Investigators
Principal Investigator: Hugh Kingston, Dr. Mahidol Oxford Tropical Medicine Research Unit

Publications:
Resuscitation Council (UK) Resuscitation 2010 Guidelines Edited by Jerry P. Nolan ISBN 978-1-903812-21-1
Leopold SJ, personal communication, November 2013.
The 1997 Resuscitation Guidelines for use in the United Kingdom April 1997. Resuscitation Council (UK) Publication.
Guidelines for the treatment of malaria. World Health Organisation 2010. 2nd edition.

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02427633     History of Changes
Other Study ID Numbers: BAKMAL1405
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

Keywords provided by University of Oxford:
recovery position
comatose
resource limited