AnesthesiaNCT02694705
Assessment of Preoxygenation Strategies in the Prehospital Environment
A study testing Continuous Positive Airway Pressure (CPAP), Bag-Valve-Mask (BVM) and Non-rebreather Mask (NRM) in people with Anesthesia and Hypoxia, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Hypoxia
- What is being tested?
- Continuous Positive Airway Pressure (CPAP), Bag-Valve-Mask (BVM) and Non-rebreather Mask (NRM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Jul 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers
Who cannot join
- Pregnancy
- Respiratory disease
- Bearded
- Facial abnormality
- Edentulous
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Essex & Herts Air Ambulance Trust
Earls Colne, Essex, CO6 2NS
About this study
Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.
Read the detailed description
Prospective randomised interventional study.
Healthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.
The techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:
- Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.
- Bag-valve-mask device (BVM) with 15 l/min oxygen flow.
- Non-rebreather mask (NRM) device with 15 l/min oxygen flow.
Volunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).
- Conditions
- Anesthesia, Hypoxia
- Being tested
- Continuous Positive Airway Pressure (CPAP), Bag-Valve-Mask (BVM), Non-rebreather Mask (NRM)
- Keywords
- Oxygen Inhalation Therapy, Intubation, Emergency Medicine
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
Bag-Valve-Mask (BVM)Device
Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
Non-rebreather Mask (NRM)Device
Preoxygenation provided by NRM, oxygen flow rate 15 l/min
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | 3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| BVM | Experimental | 3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute. Receives: Device: Bag-Valve-Mask (BVM) |
| NRM | Experimental | 3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute. Receives: Device: Non-rebreather Mask (NRM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Expired Oxygen Concentration
Measure of denitrogenation efficacy
Measured: 3 minutes
Secondary outcomes (1)
Ease of breathing assessment using a visual analogue scale
Visual analogue scale to assess subjective ease of breathing through each device
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Essex and Herts Air Ambulance
- Responsible party
- Principal investigator, Christopher Groombridge, Queen Mary University of London
- Investigators
- Christopher J Groombridge, MBBS, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694705
- Sponsor's protocol ID
- QMERC2015/69
- Status last verified
- Sep 2016
- First submitted
- 24 Feb 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.
PubMed 26728311
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Preoxygenation Strategies in the Prehospital Environment
- ClinicalTrials.gov ID
- NCT02694705
- Acronym / sponsor ID
- QMERC2015/69
- Conditions
- Anesthesia, Hypoxia
- Keywords
- Oxygen Inhalation Therapy, Intubation, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Essex and Herts Air Ambulance
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Feb 2016 (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.
Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.
Detailed description
Prospective randomised interventional study.
Healthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.
The techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:
- Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.
- Bag-valve-mask device (BVM) with 15 l/min oxygen flow.
- Non-rebreather mask (NRM) device with 15 l/min oxygen flow.
Volunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: Continuous Positive Airway Pressure (CPAP)3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%. |
| BVM | Experimental | Device: Bag-Valve-Mask (BVM)3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute. |
| NRM | Experimental | Device: Non-rebreather Mask (NRM)3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult volunteers
Key exclusion criteria (5 listed)
- Pregnancy
- Respiratory disease
- Bearded
- Facial abnormality
- Edentulous
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator | Device | CPAP |
| Bag-Valve-Mask (BVM)Preoxygenation provided by BVM device, oxygen flow rate 15 l/min | Device | BVM |
| Non-rebreather Mask (NRM)Preoxygenation provided by NRM, oxygen flow rate 15 l/min | Device | NRM |
Primary outcome
Fractional Expired Oxygen Concentration
Time frame: 3 minutes
Measure of denitrogenation efficacy
1 secondary outcome
Ease of breathing assessment using a visual analogue scale
Time frame: 3 minutes
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 30 Sep 2016.
- Background: PubMed 26728311Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.
- Individual participant dataSharing planned: No
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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.
Christopher J Groombridge, MBBS principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP), Bag-Valve-Mask (BVM) and Non-rebreather Mask (NRM) in people with Anesthesia and Hypoxia, run by Queen Mary University of London at 1 site in United Kingdom.
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 1 inclusion and 5 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 30 Sep 2016. 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 United Kingdom. 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?
Fractional Expired Oxygen Concentration (time frame: 3 minutes). 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 NCT02694705, which also lists 1 linked publication.
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 30 Sep 2016.