Severe Obesity Design as BMI > 35kg/m2PREOPTI-POOPNCT03106441
Preoxygenation Optimisation in Obese Patients
A study testing High flow oxygen therapy by nasal cannula. Optiflow® and Facial mask oxygenation in BIPAP ventilation in people with Severe Obesity Design as BMI > 35kg/m2, run by Nantes University Hospital at 1 site in France.
Trial summary
Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Obesity Design as BMI > 35kg/m2
- What is being tested?
- High flow oxygen therapy by nasal cannula. Optiflow® and Facial mask oxygenation in BIPAP ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2017to 12 Apr 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patient with BMI > 35kg/m2
- Age between 18 and 80 years
- Requiring a crash induction sequence for oro-tracheal intubation.
Who cannot join
- Pulse oxymetry < 90% in ambient air
- Haemodynamic instability
- Burned patient
- Indication of intubation vigil in spontaneous ventilation
- Patients with a documented Cormack IV exposition before inclusion
- Protected adult
Show all 10Show fewer
- Pregnancy
- Lack of consent
- Patient already enrolled in an other randomized study looking forward improving preoxygenation quality.
- Lack of French social protection
Trial locations and contacts
1 site in 1 country.
France1 site
Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
Nantes, 44093
About this study
Official title: PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "
Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients
Read the detailed description
This study will be designed as followed : Patients will be randomized in 2 groups :
- Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
- Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.
- Conditions
- Severe Obesity Design as BMI > 35kg/m2
- Being tested
- High flow oxygen therapy by nasal cannula. Optiflow®, Facial mask oxygenation in BIPAP ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygen therapy by nasal cannula. Optiflow®Device
Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
Facial mask oxygenation in BIPAP ventilationDevice
Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision
| Study group | Role | What they receive |
|---|---|---|
| High flow oxygen therapy by nasal cannula | Experimental | Experimental Device : High flow oxygen therapy by nasal cannula. Receives: Device: High flow oxygen therapy by nasal cannula. Optiflow® |
| Facial mask oxygenation in BIPAP ventilation | Active comparator | Active Comparator: Facial mask oxygenation in BIPAP ventilation Receives: Device: Facial mask oxygenation in BIPAP ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired fraction of oxygen at the end of intubation
To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation.
Measured: 2 minutes
Secondary outcomes (3)
Improvement of quality of preoxygenation
duration of proceedings
Measured: 4 minutes
Reduction in side effects incidence related to intubation
Notification of adverse events during the intubation period
Measured: 1 hour
morbi-mortality during surgery
Per and postoperative complication rate
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start21 Jun 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
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 Severe Obesity Design as BMI > 35kg/m2Studies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Asehnoune, PHD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106441
- Sponsor's protocol ID
- RC17_0046
- Acronym
- PREOPTI-POOP
- Status last verified
- Sep 2018
- First submitted
- 28 Mar 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vourc'h M, Baud G, Feuillet F, Blanchard C, Mirallie E, Guitton C, Jaber S, Asehnoune K. High-flow Nasal Cannulae Versus Non-invasive Ventilation for Preoxygenation of Obese Patients: The PREOPTIPOP Randomized Trial. EClinicalMedicine. 2019 Jun 5;13:112-119. doi: 10.1016/j.eclinm.2019.05.014. eCollection 2019 Aug.
PubMed 31528849
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "
- ClinicalTrials.gov ID
- NCT03106441
- Acronym / sponsor ID
- PREOPTI-POOP / RC17_0046
- Conditions
- Severe Obesity Design as BMI > 35kg/m2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 10 Apr 2017 (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.
Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients
Detailed description
This study will be designed as followed : Patients will be randomized in 2 groups :
- Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
- Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow oxygen therapy by nasal cannula | Experimental | Device: High flow oxygen therapy by nasal cannula. Optiflow®Experimental Device : High flow oxygen therapy by nasal cannula. |
| Facial mask oxygenation in BIPAP ventilation | Active comparator | Device: Facial mask oxygenation in BIPAP ventilationActive Comparator: Facial mask oxygenation in BIPAP ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese patient with BMI > 35kg/m2
- Age between 18 and 80 years
- Requiring a crash induction sequence for oro-tracheal intubation.
Key exclusion criteria (10 listed)
- Pulse oxymetry < 90% in ambient air
- Haemodynamic instability
- Burned patient
- Indication of intubation vigil in spontaneous ventilation
- Patients with a documented Cormack IV exposition before inclusion
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 |
|---|---|---|
| High flow oxygen therapy by nasal cannula. Optiflow®Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation. | Device | High flow oxygen therapy by nasal cannula |
| Facial mask oxygenation in BIPAP ventilationPatients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision | Device | Facial mask oxygenation in BIPAP ventilation |
Primary outcome
Expired fraction of oxygen at the end of intubation
Time frame: 2 minutes
To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation.
3 secondary outcomes
Improvement of quality of preoxygenation
Time frame: 4 minutes
Reduction in side effects incidence related to intubation
Time frame: 1 hour
morbi-mortality during surgery
Time frame: 6 hour
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 14 Sep 2026.
- Results publication: PubMed 31528849Vourc'h M, Baud G, Feuillet F, Blanchard C, Mirallie E, Guitton C, Jaber S, Asehnoune K. High-flow Nasal Cannulae Versus Non-invasive Ventilation for Preoxygenation of Obese Patients: The PREOPTIPOP Randomized Trial. EClinicalMedicine. 2019 Jun 5;13:112-119. doi: 10.1016/j.eclinm.2019.05.014. eCollection 2019 Aug.
- Individual participant dataSharing planned: No
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.
Karim Asehnoune, PHD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen therapy by nasal cannula. Optiflow® and Facial mask oxygenation in BIPAP ventilation in people with Severe Obesity Design as BMI > 35kg/m2, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 10 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 14 Sep 2026. 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 France. 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?
Expired fraction of oxygen at the end of intubation (time frame: 2 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 NCT03106441, 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 14 Sep 2026.