Intubation;DifficultPREOPTI-DAMNCT03604120
Preoxygenation for Difficult Airway Management
A study testing Preoxygenation with high flow therapy by nasal cannula and Preoxygenation by standard Facial mask in people with Intubation;Difficult, run by Nantes University Hospital at 1 site in France.
Trial summary
Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Preoxygenation with high flow therapy by nasal cannula and Preoxygenation by standard Facial mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2018to 8 Mar 2021
- 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
- Patients 18 years of aged and over
- And anticipated difficult intubation
- And requiring a rapid sequence induction for laryngoscopic intubation
- Or requiring a fiberoptic intubation
Who cannot join
- BMI > 35
- Pulse oxymetry < 90% in ambient air
- Haemodynamic instability
- Pregnancy
- Protected adult
- Lack of consent
- Patient already enrolled in another randomized study looking forward improving preoxygenation quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial
Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation
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 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation.
- Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.
- Conditions
- Intubation;Difficult
- Being tested
- Preoxygenation with high flow therapy by nasal cannula, Preoxygenation by standard Facial mask
- Keywords
- Preoxygenation, High flow nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoxygenation with high flow therapy by nasal cannulaDevice
Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before fiber-optic or laryngoscopic intubation. The device will be maintained in place throughout the intubation procedure in order to achieve oxygenation.
Preoxygenation by standard Facial maskDevice
- For Fiber-optic intubation: patients will receive a 4 minutes FIBROXY facial mask preoxygenation with FiO2=100%. The FIBROXY facial mask will be maintained in place during the intubation procedure.
- For Laryngoscopic intubation: patients will receive a 4 minutes standard facial mask preoxygenation with FiO2=100%. The standard facial mask will be removed after crash induction to proceed to intubation.
| Study group | Role | What they receive |
|---|---|---|
| Preoxygenation with high flow therapy by nasal cannula | Experimental | High flow oxygen therapy by nasal cannula. Receives: Device: Preoxygenation with high flow therapy by nasal cannula |
| Preoxygenation by standard Facial mask | Active comparator | Patients randomized in "STANDARD FACIAL MASK" group will receive a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction or Fiber-optic intubation under spontaneous ventilation. Receives: Device: Preoxygenation by standard Facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.
To determine whether High-Flow nasal cannula used for preoxygenation and oxygenation during intubation, is more efficient than standard care during difficult intubation. This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry.
Measured: 4 minutes
Secondary outcomes (3)
Improvement of quality of preoxygenation
duration of proceedings
Measured: 4 minutes
Reduction in side effects incidence related to intubation
Measured: 6 hours
Morbi-mortality during surgery.
Per and postoperative complication rate
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start19 Sep 2018
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickael VOURC'H, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604120
- Sponsor's protocol ID
- RC17_0474
- Acronym
- PREOPTI-DAM
- Status last verified
- May 2021
- First submitted
- 22 Jun 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vourc'h M, Huard D, Le Penndu M, Deransy R, Surbled M, Malidin M, Mahe PJ, Guitton C, Roquilly A, Malard O, Feuillet F, Rozec B, Asehnoune K. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998. doi: 10.1016/j.eclinm.2023.101998. eCollection 2023 Jun.
PubMed 37251624Vourc'h M, Huard D, Feuillet F, Baud G, Guichoux A, Surbled M, Tissot M, Chiffoleau A, Guitton C, Jaber S, Asehnoune K. Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study. BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909.
PubMed 31028041
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-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03604120
- Acronym / sponsor ID
- PREOPTI-DAM / RC17_0474
- Conditions
- Intubation;Difficult
- Keywords
- Preoxygenation, High flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 27 Jul 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.
Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation
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 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation.
- Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoxygenation with high flow therapy by nasal cannula | Experimental | Device: Preoxygenation with high flow therapy by nasal cannulaHigh flow oxygen therapy by nasal cannula. |
| Preoxygenation by standard Facial mask | Active comparator | Device: Preoxygenation by standard Facial maskPatients randomized in "STANDARD FACIAL MASK" group will receive a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction or Fiber-optic intubation under spontaneous ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of aged and over
- And anticipated difficult intubation
- And requiring a rapid sequence induction for laryngoscopic intubation
- Or requiring a fiberoptic intubation
Key exclusion criteria (7 listed)
- BMI > 35
- Pulse oxymetry < 90% in ambient air
- Haemodynamic instability
- Pregnancy
- Protected adult
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 |
|---|---|---|
| Preoxygenation with high flow therapy by nasal cannulaPreoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before fiber-optic or laryngoscopic intubation. The device will be maintained in place throughout the intubation procedure in order to achieve oxygenation. | Device | Preoxygenation with high flow therapy by nasal cannula |
| Preoxygenation by standard Facial mask* For Fiber-optic intubation: patients will receive a 4 minutes FIBROXY facial mask preoxygenation with FiO2=100%. The FIBROXY facial mask will be maintained in place during the intubation procedure. * For Laryngoscopic intubation: patients will receive a 4 minutes standard facial mask preoxygenation with FiO2=100%. The standard facial mask will be removed after crash induction to proceed to intubation. | Device | Preoxygenation by standard Facial mask |
Primary outcome
Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.
Time frame: 4 minutes
To determine whether High-Flow nasal cannula used for preoxygenation and oxygenation during intubation, is more efficient than standard care during difficult intubation. This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry.
3 secondary outcomes
Improvement of quality of preoxygenation
Time frame: 4 minutes
Reduction in side effects incidence related to intubation
Time frame: 6 hours
Morbi-mortality during surgery.
Time frame: 6 hours
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 37251624Vourc'h M, Huard D, Le Penndu M, Deransy R, Surbled M, Malidin M, Mahe PJ, Guitton C, Roquilly A, Malard O, Feuillet F, Rozec B, Asehnoune K. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998. doi: 10.1016/j.eclinm.2023.101998. eCollection 2023 Jun.
- Derived from this study: PubMed 31028041Vourc'h M, Huard D, Feuillet F, Baud G, Guichoux A, Surbled M, Tissot M, Chiffoleau A, Guitton C, Jaber S, Asehnoune K. Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study. BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909.
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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.
Mickael VOURC'H, PH 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 Preoxygenation with high flow therapy by nasal cannula and Preoxygenation by standard Facial mask in people with Intubation;Difficult, 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 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 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?
Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure. (time frame: 4 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 NCT03604120, which also lists 2 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 14 Sep 2026.