ObesityNCT03428256
Pre-oxygenation Methods in Bariatric Patients
A study testing Optiflow and THRIVE technique and Standard anaesthetic face mask in people with Obesity and Anesthesia, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of the study is to compare effectiveness of different methods of achieving pre-oxygenation in bariatric patients. The investigators intend to compare facemask pre-oxygenation with a high-flow humidified nasal oxygen. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Anesthesia, Bariatric Surgery Candidate
- What is being tested?
- Optiflow and THRIVE technique and Standard anaesthetic face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 15 Oct 2019
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- Undergoing general anaesthesia .
- Between the ages of 18 and 80 years.
- Body mass index (BMI) greater than 40 Kgm-2.
Who cannot join
- Unable to give informed consent.
- Significant cardiac history which is defined as current angina, myocardial infarction <12 months before the date of the procedure.
- Significant peripheral vascular disease defined as claudication on minimal exertion or Ankle-Brachial index of <0.7, a stroke or a transient ischaemic attack <12 months before the procedure.
- Presence of significant heart-valve disease or congestive heart failure.
- Significant lower respiratory disease including brittle asthma; chronic obstructive pulmonary disease (GOLD stages 3 or 4).
- Strong predictors of both difficult intubation and difficult facemask ventilation on anaesthetic airway assessment.
- Patient with American Society of Anesthesiologists (ASA) grade of 4 for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Comparison of Effectiveness of Facemask Preoxygenation and Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Bariatric Patients Undergoing General Anaesthesia
The purpose of the study is to compare effectiveness of different methods of achieving pre-oxygenation in bariatric patients. The investigators intend to compare facemask pre-oxygenation with a high-flow humidified nasal oxygen.
The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of apnoea.
Read the detailed description
General anaesthesia involves giving patients anaesthetic and muscle relaxant medications to allow transition to sleep and airway relaxation to permit laryngoscopy, respectively. During laryngoscopy, a breathing tube is placed to 'secure' the airway. There is therefore a length of time from administration of these medications to when the breathing tube is placed, when the patient is not breathing and the airway is not secured. This time is known as apnoea time. In a patient who is not breathing, blood oxygen levels fall to dangerously-low levels, within 1-2 minutes. In order to prevent this, patients breathe 100% oxygen before induction of anaesthesia as part of a process known as pre-oxygenation. There are different ways of delivering pre-oxygenation, but the common aim is to increase the oxygen reservoir within the lungs to give the anaesthetist more time to place the breathing tube. With good pre-oxygenation, apnoea times of up to 7 minutes are possible.
Apnoea time is a potentially hazardous period during induction of anaesthesia and it is particularly so in patients with severe obesity. On the one hand, obesity makes the upper airway anatomy difficult, and on the other hand, lung collapse (atelectasis) caused by abdominal contents compressing the base of the lungs reduces the amount of oxygen available within the lungs. Apnoea time can be as short of 30 seconds. Identifying the most effective method of pre-oxygenating bariatric patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.
- Conditions
- Obesity, Anesthesia, Bariatric Surgery Candidate
- Being tested
- Optiflow and THRIVE technique, Standard anaesthetic face mask
- Keywords
- Obesity, Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow and THRIVE techniqueDevice
Nasal high flow humidified oxygen
Standard anaesthetic face maskDevice
Oxygen delivery via an anaesthetic facemask
| Study group | Role | What they receive |
|---|---|---|
| Pre-oxygenation with a standard anaesthetic face mask | Active comparator | Pre-oxygenation delivered in the standard way; 3 minutes, Fraction of inspired oxygen (FiO2) 1.0, 8 vital capacity breaths in the last minute Receives: Device: Standard anaesthetic face mask |
| Pre-oxygenation using Optiflow and THRIVE technique | Experimental | Pre-oxygenation delivered via nasal high flow humidified oxygen (Optiflow) and THRIVE technique. Gradually increased to 70 litres/minute, mouth closed, 8 vital capacity breaths in the last minute Receives: Device: Optiflow and THRIVE technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 92%. Comparing pre-oxygenation with standard face mask oxygen or THRIVE technique.
Pre-oxygenation is delivered either by a standard anaesthetic face mask or the THRIVE technique. General anaesthesia is induced and muscle relaxation is given. The time for the peripheral oxygen saturations (SpO2) to fall to 92% is recorded. When this occurs the trial is stopped and the patient is intubated.
If 18 minutes is reached before SpO2 = 92% then the trial is stopped.
Measured: Eighteen (18) minutes maximum
Secondary outcomes (1)
The correlation between Oxygen Reserve Index (ORI) and pre-oxygenation with either a standard anaesthetic face mask or the THRIVE technique.
The investigators will simultaneously record the ORI. The ORI readings will then be correlated with the SpO2 and arterial oxygen content.
Measured: Eighteen (18) minutes maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Oct 2018
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
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 ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Cousins, FRCA FFICM, Principal investigator, Imperial College Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428256
- Sponsor's protocol ID
- 17SM3844
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2017
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schutzer-Weissmann J, Wojcikiewicz T, Karmali A, Lukosiute A, Sun R, Kanji R, Ahmed AR, Purkayastha S, Brett SJ, Cousins J. Apnoeic oxygenation in morbid obesity: a randomised controlled trial comparing facemask and high-flow nasal oxygen delivery. Br J Anaesth. 2023 Jan;130(1):103-110. doi: 10.1016/j.bja.2021.12.011. Epub 2022 Jan 11.
PubMed 35027169
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Comparison of Effectiveness of Facemask Preoxygenation and Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Bariatric Patients Undergoing General Anaesthesia
- ClinicalTrials.gov ID
- NCT03428256
- Acronym / sponsor ID
- 17SM3844
- Conditions
- Obesity, Anesthesia, Bariatric Surgery Candidate
- Keywords
- Obesity, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- 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.
The purpose of the study is to compare effectiveness of different methods of achieving pre-oxygenation in bariatric patients. The investigators intend to compare facemask pre-oxygenation with a high-flow humidified nasal oxygen.
The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of apnoea.
Detailed description
General anaesthesia involves giving patients anaesthetic and muscle relaxant medications to allow transition to sleep and airway relaxation to permit laryngoscopy, respectively. During laryngoscopy, a breathing tube is placed to 'secure' the airway. There is therefore a length of time from administration of these medications to when the breathing tube is placed, when the patient is not breathing and the airway is not secured. This time is known as apnoea time. In a patient who is not breathing, blood oxygen levels fall to dangerously-low levels, within 1-2 minutes. In order to prevent this, patients breathe 100% oxygen before induction of anaesthesia as part of a process known as pre-oxygenation. There are different ways of delivering pre-oxygenation, but the common aim is to increase the oxygen reservoir within the lungs to give the anaesthetist more time to place the breathing tube. With good pre-oxygenation, apnoea times of up to 7 minutes are possible.
Apnoea time is a potentially hazardous period during induction of anaesthesia and it is particularly so in patients with severe obesity. On the one hand, obesity makes the upper airway anatomy difficult, and on the other hand, lung collapse (atelectasis) caused by abdominal contents compressing the base of the lungs reduces the amount of oxygen available within the lungs. Apnoea time can be as short of 30 seconds. Identifying the most effective method of pre-oxygenating bariatric patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-oxygenation with a standard anaesthetic face mask | Active comparator | Device: Standard anaesthetic face maskPre-oxygenation delivered in the standard way; 3 minutes, Fraction of inspired oxygen (FiO2) 1.0, 8 vital capacity breaths in the last minute |
| Pre-oxygenation using Optiflow and THRIVE technique | Experimental | Device: Optiflow and THRIVE techniquePre-oxygenation delivered via nasal high flow humidified oxygen (Optiflow) and THRIVE technique. Gradually increased to 70 litres/minute, mouth closed, 8 vital capacity breaths in the last minute |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide informed consent.
- Undergoing general anaesthesia .
- Between the ages of 18 and 80 years.
- Body mass index (BMI) greater than 40 Kgm-2.
Key exclusion criteria (7 listed)
- Unable to give informed consent.
- Significant cardiac history which is defined as current angina, myocardial infarction <12 months before the date of the procedure.
- Significant peripheral vascular disease defined as claudication on minimal exertion or Ankle-Brachial index of <0.7, a stroke or a transient ischaemic attack <12 months before the procedure.
- Presence of significant heart-valve disease or congestive heart failure.
- Significant lower respiratory disease including brittle asthma; chronic obstructive pulmonary disease (GOLD stages 3 or 4).
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 |
|---|---|---|
| Optiflow and THRIVE techniqueNasal high flow humidified oxygen | Device | Pre-oxygenation using Optiflow and THRIVE technique |
| Standard anaesthetic face maskOxygen delivery via an anaesthetic facemask | Device | Pre-oxygenation with a standard anaesthetic face mask |
Primary outcome
Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 92%. Comparing pre-oxygenation with standard face mask oxygen or THRIVE technique.
Time frame: Eighteen (18) minutes maximum
Pre-oxygenation is delivered either by a standard anaesthetic face mask or the THRIVE technique. General anaesthesia is induced and muscle relaxation is given. The time for the peripheral oxygen saturations (SpO2) to fall to 92% is recorded. When this occurs the trial is stopped and the patient is intubated. If 18 minutes is reached before SpO2 = 92% then the trial is stopped.
1 secondary outcome
The correlation between Oxygen Reserve Index (ORI) and pre-oxygenation with either a standard anaesthetic face mask or the THRIVE technique.
Time frame: Eighteen (18) minutes maximum
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 18 Oct 2019.
- Derived from this study: PubMed 35027169Schutzer-Weissmann J, Wojcikiewicz T, Karmali A, Lukosiute A, Sun R, Kanji R, Ahmed AR, Purkayastha S, Brett SJ, Cousins J. Apnoeic oxygenation in morbid obesity: a randomised controlled trial comparing facemask and high-flow nasal oxygen delivery. Br J Anaesth. 2023 Jan;130(1):103-110. doi: 10.1016/j.bja.2021.12.011. Epub 2022 Jan 11.
- 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.
Jonathan Cousins, FRCA FFICM principal investigator
Imperial College Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow and THRIVE technique and Standard anaesthetic face mask in people with Obesity and Anesthesia, run by Imperial College 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 4 inclusion and 7 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 18 Oct 2019. 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?
Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 92%. Comparing pre-oxygenation with standard face mask oxygen or THRIVE technique. (time frame: Eighteen (18) minutes maximum). 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 NCT03428256, 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 18 Oct 2019.