ComaNCT02427633
Study of Body Positions in Unconsciousness
A study testing Educational Intervention UKRC 1997 and Educational Intervention UKRC 2010 in people with Coma, run by University of Oxford at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma
- What is being tested?
- Educational Intervention UKRC 1997 and Educational Intervention UKRC 2010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,540 participants
- Where
- 1 siteBangladesh
- Study dates
- 23 Aug 2014to 21 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coma
- Being tested
- Educational Intervention UKRC 1997, Educational Intervention UKRC 2010
- Keywords
- recovery position, comatose, resource limited
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention UKRC 1997Other
Educational poster intervention indicating the modified UKRC 1997 recovery position
Educational Intervention UKRC 2010Other
Educational poster intervention indicating the modified UKRC 2010 recovery position
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Randomized to standard care (control group) - observations only |
| UKRC 1997 | Experimental | Randomized to modified UKRC 1997 - Intervention and Observations Receives: Other: Educational Intervention UKRC 1997 |
| UKRC 2010 | Experimental | Randomized to modified UKRC 2010 - Intervention and Observations Receives: Other: Educational Intervention UKRC 2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of aspiration pneumonitis or pneumonia
Measured: 48 hours after GCS13
Secondary outcomes (17)
Proportion of patients developing hypoxia
Measured: 48 hours after GCS13,
Development of pneumonia or pneumonitis, assessed individually
Measured: 48 hours after GCS13
Mortality
Measured: 7 days post discharge/last follow-up
Time to mortality
Measured: 7 days post discharge/last follow-up
Coma recovery time, defined as time to GCS 15
Measured: during hospitalization (defined as time to GCS 15), expected less than 4 weeks
The number of documented episodes of hypoxia
Measured: 48 hours after GCS 13
Percentage of observations in the recovery position
Measured: whilst GCS<12, expected less than 2 months
Modified Rankin scale
Measured: on discharge, expected less than 2 months
Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury
Measured: whilst GCS<12, expected less than 2 months
Proportion of patients developing a pressure sore
Measured: whilst GCS<12, expected less than 2 months
Proportion of patients developing a venous thrombosis,
Measured: whilst GCS<12, expected less than 2 months
Proportion of patients developing a new arm or leg peripheral nerve injury
Measured: during hospitalization, expected less than 2 months
Proportion of patients developing a new arm or leg joint injury
Measured: during hospitalization, expected less than 2 months
Trends in Blood presure
measure Systolic and diastolic blood pressure levels
Measured: during hospitalization, expected less than 2 months
Trends in heart rate
Measured: during hospitalization, expected less than 2 months
Proportion of patients developing peripheral venous cannula function
Measured: whilst GCS<12, expected less than 2 months
time to hypoxia
Measured: 48 hours after GCS13, expected less than 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study start23 Aug 2014
- Primary completion21 Mar 2020
- Study completion21 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Chittagong Medical College and Hospital
- Responsible party
- Sponsor
- Investigators
- Hugh Kingston, Dr., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427633
- Sponsor's protocol ID
- BAKMAL1405
- Status last verified
- Oct 2020
- First submitted
- 12 Jan 2015
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22110624Koster 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.
PubMed 20956051Resuscitation Council (UK) Resuscitation 2010 Guidelines Edited by Jerry P. Nolan ISBN 978-1-903812-21-1
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.
PubMed 20956221Leopold 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.
PubMed 645722Adnet 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.
PubMed 8676684Markenson 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.
PubMed 20956261Adnet 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.
PubMed 10321664Turner 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.
PubMed 10078804Fulstow 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.
PubMed 8210736Kumar 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.
PubMed 8821237Rathgeber 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.
PubMed 8809913Doxey 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.
PubMed 10078805The 1997 Resuscitation Guidelines for use in the United Kingdom April 1997. Resuscitation Council (UK) Publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study of the Use of Recovery Positions for Comatose Patients in a Resource Limited Setting
- ClinicalTrials.gov ID
- NCT02427633
- Acronym / sponsor ID
- BAKMAL1405
- Conditions
- Coma
- Keywords
- recovery position, comatose, resource limited
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,540 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Chittagong Medical College and Hospital
- Study start
- 23 Aug 2014 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Randomized to standard care (control group) - observations only |
| UKRC 1997 | Experimental | Other: Educational Intervention UKRC 1997Randomized to modified UKRC 1997 - Intervention and Observations |
| UKRC 2010 | Experimental | Other: Educational Intervention UKRC 2010Randomized to modified UKRC 2010 - Intervention and Observations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention UKRC 1997Educational poster intervention indicating the modified UKRC 1997 recovery position | Other | UKRC 1997 |
| Educational Intervention UKRC 2010Educational poster intervention indicating the modified UKRC 2010 recovery position | Other | UKRC 2010 |
Primary outcome
Composite of aspiration pneumonitis or pneumonia
Time frame: 48 hours after GCS13
17 secondary outcomes
Proportion of patients developing hypoxia
Time frame: 48 hours after GCS13,
Development of pneumonia or pneumonitis, assessed individually
Time frame: 48 hours after GCS13
Mortality
Time frame: 7 days post discharge/last follow-up
Time to mortality
Time frame: 7 days post discharge/last follow-up
Coma recovery time, defined as time to GCS 15
Time frame: during hospitalization (defined as time to GCS 15), expected less than 4 weeks
The number of documented episodes of hypoxia
Time frame: 48 hours after GCS 13
Percentage of observations in the recovery position
Time frame: whilst GCS<12, expected less than 2 months
Modified Rankin scale
Time frame: on discharge, expected less than 2 months
Composite of pressure sore, venous thrombosis, arm or leg peripheral nerve or joint injury
Time frame: whilst GCS<12, expected less than 2 months
Proportion of patients developing a pressure sore
Time frame: whilst GCS<12, expected less than 2 months
Proportion of patients developing a venous thrombosis,
Time frame: whilst GCS<12, expected less than 2 months
Proportion of patients developing a new arm or leg peripheral nerve injury
Time frame: during hospitalization, expected less than 2 months
Proportion of patients developing a new arm or leg joint injury
Time frame: during hospitalization, expected less than 2 months
Trends in Blood presure
Time frame: during hospitalization, expected less than 2 months
Trends in heart rate
Time frame: during hospitalization, expected less than 2 months
Proportion of patients developing peripheral venous cannula function
Time frame: whilst GCS<12, expected less than 2 months
time to hypoxia
Time frame: 48 hours after GCS13, expected less than 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 22110624Maude 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.
- Background: PubMed 20956051Koster 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.
- BackgroundResuscitation Council (UK) Resuscitation 2010 Guidelines Edited by Jerry P. Nolan ISBN 978-1-903812-21-1
- Background: PubMed 20956221Berg 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.
- BackgroundLeopold SJ, personal communication, November 2013.
- Background: PubMed 645722Huxley 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.
- Background: PubMed 8676684Adnet 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.
- Background: PubMed 20956261Markenson 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.
- Background: PubMed 10321664Adnet 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.
- Background: PubMed 10078804Turner 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.
- Background: PubMed 8210736Fulstow 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.
- Background: PubMed 8821237Kumar 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.
Related trials for Coma
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
AI-based Algorithm Development for Improved Diagnostics in the Intensive Care and Acute Stroke Setting Using Electroencephalography
Hemorrhagic Stroke, Intracerebral, Subarachnoid Haemorrhage (SAH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Kingston, Dr. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention UKRC 1997 and Educational Intervention UKRC 2010 in people with Coma, run by University of Oxford at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of aspiration pneumonitis or pneumonia (time frame: 48 hours after GCS13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427633, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.