AnesthesiaOPTIFLOWNCT03554863
High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia
A study testing Nasal High Flow Oxygen and Facial Mask in people with Anesthesia, run by CMC Ambroise Paré at 2 sites in France.
Trial summary
Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management. 1. The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Nasal High Flow Oxygen and Facial Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Nov 2018to 14 Feb 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent for participation
- Affiliation to the french social security system
- Patients benefit general anesthesia with oral intubation
Who cannot join
- Pregnant or breastfeeding patients;
- Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma);
- Patients under the protection of justice
- Patients with drained or undrained pneumothorax;
- Patients with a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room;
- Patients with coronary heart disease, heart failure or respiratory failure;
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- Patients with intracranial pathology; patients with arterial oxygen saturation <95% in the open air;
- Patients for whom the surgical procedure requires the installation of a double-lumen tube;
- Patients requiring rapid sequence induction; patients for whom the induction can not be carried out by the sequence sufentanil, propofol, rocuronium;
- Patients with sugammadex allergy;
- Patients placed under judicial protection
- Patients who have already been included in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200
Hôpital Foch
Suresnes, Île-de-France Region, 92151
About this study
Official title: Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?
Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.
- The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
- Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.
The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.
- Conditions
- Anesthesia
- Being tested
- Nasal High Flow Oxygen, Facial Mask
- Keywords
- Anesthesia genral, Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High Flow OxygenDevice
Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel
Facial MaskDevice
Preoxygenation with facial mask
| Study group | Role | What they receive |
|---|---|---|
| Facial mask | Active comparator | Not described Receives: Device: Facial Mask |
| Optiflow anesthesia | Experimental | Not described Receives: Device: Nasal High Flow Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recourse to another ventilation technique
The preoxygenation-induction-intubation period is filmed (audio and video recording) and the use of mask ventilation will be confirmed a posteriori from the audio / video recording by two reviewers.
Measured: During the preoxygenation-induction-intubation period (30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start21 Nov 2018
- Primary completion14 Feb 2019
- Study completion14 Feb 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 AnesthesiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FISCHLER Marc, MD, Study chair, Hôpital FOCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554863
- Sponsor's protocol ID
- 2017/01
- Acronym
- OPTIFLOW
- Status last verified
- Apr 2026
- First submitted
- 15 May 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tremey B, Squara P, De Labarre H, Ma S, Fischler M, Lawkoune JD, Le Guen M. Hands-free induction of general anesthesia: a randomised pilot study comparing usual care and high-flow nasal oxygen. Minerva Anestesiol. 2020 Nov;86(11):1135-1142. doi: 10.23736/S0375-9393.20.14456-0. Epub 2020 Jul 8.
PubMed 32643359
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?
- ClinicalTrials.gov ID
- NCT03554863
- Acronym / sponsor ID
- OPTIFLOW / 2017/01
- Conditions
- Anesthesia
- Keywords
- Anesthesia genral, Oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 13 Jun 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.
Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.
- The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
- Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.
The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial mask | Active comparator | Device: Facial Mask |
| Optiflow anesthesia | Experimental | Device: Nasal High Flow Oxygen |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consent for participation
- Affiliation to the french social security system
- Patients benefit general anesthesia with oral intubation
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding patients;
- Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma);
- Patients under the protection of justice
- Patients with drained or undrained pneumothorax;
- Patients with a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room;
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 |
|---|---|---|
| Nasal High Flow OxygenNasal High Flow Oxygen using Optiflow device of Fisher and Paykel | Device | Optiflow anesthesia |
| Facial MaskPreoxygenation with facial mask | Device | Facial mask |
Primary outcome
Recourse to another ventilation technique
Time frame: During the preoxygenation-induction-intubation period (30 min)
The preoxygenation-induction-intubation period is filmed (audio and video recording) and the use of mask ventilation will be confirmed a posteriori from the audio / video recording by two reviewers.
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 8 Apr 2026.
- Results publication: PubMed 32643359Tremey B, Squara P, De Labarre H, Ma S, Fischler M, Lawkoune JD, Le Guen M. Hands-free induction of general anesthesia: a randomised pilot study comparing usual care and high-flow nasal oxygen. Minerva Anestesiol. 2020 Nov;86(11):1135-1142. doi: 10.23736/S0375-9393.20.14456-0. Epub 2020 Jul 8.
- 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.
FISCHLER Marc, MD study chair
Hôpital FOCH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow Oxygen and Facial Mask in people with Anesthesia, run by CMC Ambroise Paré at 2 sites 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 12 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Recourse to another ventilation technique (time frame: During the preoxygenation-induction-intubation period (30 min)). 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 NCT03554863, 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 8 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.