Head and Neck CancerOPTINOSENCT05696288
Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation
A study testing Respiratory Gas Delivery System in people with Head and Neck Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
The high-flow oxygen therapy system, also called the THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) system, appears to provide better patient safety than conventional techniques. Panendoscopy is a very common diagnostic procedure in ENT surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Respiratory Gas Delivery System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2023to 30 Nov 2025
- 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 suffering from a head and neck cancer, most often tumor of the bucco-pharyngo-laryngeal cavities, having to carry out a diagnostic HN panendoscopy;
- Patient over 18 years of age;
- ASA < 4;
- BMI ≤ 45;
- Patient willing and able to provide written informed consent for the trial;;
- Patient affiliated with a health insurance system.
Who cannot join
- Patient with a contraindication to the Optiflow™ system as defined in the manufacturer's brochure;
- Patient with a tumor obstructing more than 80% of the glottic lumen;
- Patient with impossible intubation criteria:
- Mallampati 4 and mouth opening less than 20 mm
- Retrognathia
- Patient with:
Show all 21Show fewer
- A known intracranial pathology;
- Documented pulmonary hypertension;
- Uncontrolled epilepsy;
- Uncontrolled heart rhythm disorder;
- Pulmonary pathology with hypoxemia: Spo2 <92% in ambient air;
- Patient at high risk of a full stomach evaluated by the anesthetist;
- ASA ≥ 4
- Morbid obesity with BMI> 45;
- Obstructive upper airway tumor with functional impact;
- Known contraindication to propofol or alfentanil;
- Panendoscopy procedure to be combined with an oesogastro-duodenal fibroscopy;
- Vulnerable persons as defined by articles 64 and 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices :
- In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical investigation may be conducted only where, in addition to the conditions set out in Article 62(4)
- Pregnant or breast-feeding women who do not fall under the provisions of Article 66
- Adults subject to a legal protection order or unable to give their consent.
Trial locations and contacts
1 site in 1 country.
About this study
The high-flow oxygen therapy system, also called the THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) system, appears to provide better patient safety than conventional techniques.
Panendoscopy is a very common diagnostic procedure in ENT surgery. The general anesthesia during the diagnostic panendoscopy is a good representation of the induction stage. Indeed, the procedure of preoxygenation preceding anesthetic induction and direct laryngoscopy corresponds to the airway management that is an integral part of each general anesthesia. This is why researchers are studying it in particular to improve patient safety during difficult intubations. The paradox is that there is no consensus on the anesthetic strategy for this procedure that counts four main methods for the airway management of patients requiring an ENT panendoscopy. In our center, the investigators use, in most situations, a variant of spontaneous ventilation described by Y. Jacquet et al., with the difference that the investigators use a transglottic oxygenation probe during the procedure. During laryngoscopy, the operator positions a naso-tracheal tube after local anesthesia of the vocal cords. The oxygen flow is reduced to 3 L/min before the exploration procedure. The arrival in operating theaters of the Optiflow™ system, developed by the New Zealand Company Fisher \& Paykel Healthcare, has led to a rethinking of the way oxygen is delivered. This device allows the administration of a flow rate of up to 70 L/min while delivering heated gases.
Read the detailed description
This device allows the administration of a flow rate of up to 70 L/min while delivering heated gases. The benefit of Optiflow™ no longer needs to be demonstrated for certain intensive care patients. In the field of Anesthesia, the number of publications raised up since the increase in the non-hypoxemic apnea time during general anesthesia is never equaled by other methods.
What is known is that panendoscopy under general anesthesia in spontaneous ventilation is not unanimously accepted due to a higher risk regarding the time allowed for apnea, and laryngospasm complications. High-flow oxygen delivery provide a longer safe apnea time for patient safety. The aim of this investigation is to prove that high-flow oxygen therapy improves patient safety during general anesthesia for ENT panendoscopy. This should allow answering the question: shouldn't very high flow oxygenation be systematically offered for this procedure? Currently, there is no consensus as to the anaesthetic strategy for this procedure, if our hypothesis is verified; the Optiflow™ system could become de gold standard of the management of the upper airway during the ENT procedure.
- Conditions
- Head and Neck Cancer
- Being tested
- Respiratory Gas Delivery System
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Gas Delivery SystemProcedure or surgery
Oxygen therapy during general anesthesia for ENT panendoscopy
| Study group | Role | What they receive |
|---|---|---|
| Arm A: investigational device (Respiratory Gas Delivery System) | Experimental | Patients ventilated with the Optiflow™ system, a nasal high flow oxygenation system (NHFO) while undergoing a panendoscopy Receives: Procedure: Respiratory Gas Delivery System |
| Arm B: standard nasal oxygenation device | Active comparator | Patients ventilated according to the standard technique while undergoing a panendoscopy Receives: Procedure: Respiratory Gas Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arterial desaturation
The O2 saturation defined as SpO2 <95% will be collected each time it reaches 94% or less
Measured: 1 day, during the procédure
Secondary outcomes (10)
Measure the non-hypoxemic apnea time
Non-hypoxemic apnea time will be measured as soon as the SpO2 parameter is between 100 and 95%
Measured: 1 day, during the procédure
Incidence of the use of manual ventilation
Interruption of the surgical procedure for use of manual ventilation with a facemask will be recorded.
Measured: 1 day, during the procedure
Incidence of the use of tracheal intubation
Conversion from the OHD oxygenation technique to the standard technique will be recorded
Measured: 1 day, during the procedure
Incidence of the use of neuromuscular blocking drugs
The use of neuromuscular blocking drugs will be recorded
Measured: 1 day, during the procedure
Incidence of emergency tracheostomy
The performance of an emergency tracheostomy will be recorded
Measured: 1 day, during the procedure
Incidence of complications in SSPI and the complication rate on D1 after the panendoscopy procedure
Occurrence of complications in SSPI and on D1 after the panendoscopy procedure will be recorded. Complication in SSPI is define as prolonged desaturation requiring a supply of ventilation whatever the modalities, symptomatic hypercapnia or cardiovascular complications.
Measured: Through study completion, up to 2 days
Correlation between sedation dose and duration of non-hypoxemic apnea
Correlation between the dose of sedation and the duration of non-hypoxemic apnea will be evaluated using Spearman's R coefficient
Measured: 1 day, during the procedure
Evaluation of the technique fluctuation
Hypoxic desaturation will be reported by acts and by technique
Measured: 1 day, during the procedure
Operator satisfaction
Operator's satisfaction will be noted at the end of each procedure using a visual analogic scale from 1 to 6
Measured: 1 day, after the procedure
Patient satisfaction
Patient satisfaction will be recorded using a scale from 1 to 6
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start12 Apr 2023
- Primary completion30 May 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare the incidence of oxygen desaturation in patients ventilated with the Optiflow™ system to that of patients treated according to the standard technique.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Henri KOULMANN, MD, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696288
- Sponsor's protocol ID
- 2022/16
- Acronym
- OPTINOSE
- Status last verified
- Mar 2026
- First submitted
- 11 Jan 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation
- ClinicalTrials.gov ID
- NCT05696288
- Acronym / sponsor ID
- OPTINOSE / 2022/16
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 25 Jan 2023 (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 high-flow oxygen therapy system, also called the THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) system, appears to provide better patient safety than conventional techniques.
Panendoscopy is a very common diagnostic procedure in ENT surgery. The general anesthesia during the diagnostic panendoscopy is a good representation of the induction stage. Indeed, the procedure of preoxygenation preceding anesthetic induction and direct laryngoscopy corresponds to the airway management that is an integral part of each general anesthesia. This is why researchers are studying it in particular to improve patient safety during difficult intubations. The paradox is that there is no consensus on the anesthetic strategy for this procedure that counts four main methods for the airway management of patients requiring an ENT panendoscopy. In our center, the investigators use, in most situations, a variant of spontaneous ventilation described by Y. Jacquet et al., with the difference that the investigators use a transglottic oxygenation probe during the procedure. During laryngoscopy, the operator positions a naso-tracheal tube after local anesthesia of the vocal cords. The oxygen flow is reduced to 3 L/min before the exploration procedure. The arrival in operating theaters of the Optiflow™ system, developed by the New Zealand Company Fisher \& Paykel Healthcare, has led to a rethinking of the way oxygen is delivered. This device allows the administration of a flow rate of up to 70 L/min while delivering heated gases.
Detailed description
This device allows the administration of a flow rate of up to 70 L/min while delivering heated gases. The benefit of Optiflow™ no longer needs to be demonstrated for certain intensive care patients. In the field of Anesthesia, the number of publications raised up since the increase in the non-hypoxemic apnea time during general anesthesia is never equaled by other methods.
What is known is that panendoscopy under general anesthesia in spontaneous ventilation is not unanimously accepted due to a higher risk regarding the time allowed for apnea, and laryngospasm complications. High-flow oxygen delivery provide a longer safe apnea time for patient safety. The aim of this investigation is to prove that high-flow oxygen therapy improves patient safety during general anesthesia for ENT panendoscopy. This should allow answering the question: shouldn't very high flow oxygenation be systematically offered for this procedure? Currently, there is no consensus as to the anaesthetic strategy for this procedure, if our hypothesis is verified; the Optiflow™ system could become de gold standard of the management of the upper airway during the ENT procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare the incidence of oxygen desaturation in patients ventilated with the Optiflow™ system to that of patients treated according to the standard technique.
| Arm | Type | Receives |
|---|---|---|
| Arm A: investigational device (Respiratory Gas Delivery System) | Experimental | Procedure: Respiratory Gas Delivery SystemPatients ventilated with the Optiflow™ system, a nasal high flow oxygenation system (NHFO) while undergoing a panendoscopy |
| Arm B: standard nasal oxygenation device | Active comparator | Procedure: Respiratory Gas Delivery SystemPatients ventilated according to the standard technique while undergoing a panendoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suffering from a head and neck cancer, most often tumor of the bucco-pharyngo-laryngeal cavities, having to carry out a diagnostic HN panendoscopy;
- Patient over 18 years of age;
- ASA < 4;
- BMI ≤ 45;
- Patient willing and able to provide written informed consent for the trial;;
Key exclusion criteria (21 listed)
- Patient with a contraindication to the Optiflow™ system as defined in the manufacturer's brochure;
- Patient with a tumor obstructing more than 80% of the glottic lumen;
- Patient with impossible intubation criteria:
- Patient with:
- Patient at high risk of a full stomach evaluated by the anesthetist;
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 |
|---|---|---|
| Respiratory Gas Delivery SystemOxygen therapy during general anesthesia for ENT panendoscopy | Procedure or surgery | Arm A: investigational device (Respiratory Gas Delivery System), Arm B: standard nasal oxygenation device |
Primary outcome
Incidence of arterial desaturation
Time frame: 1 day, during the procédure
The O2 saturation defined as SpO2 <95% will be collected each time it reaches 94% or less
10 secondary outcomes
Measure the non-hypoxemic apnea time
Time frame: 1 day, during the procédure
Incidence of the use of manual ventilation
Time frame: 1 day, during the procedure
Incidence of the use of tracheal intubation
Time frame: 1 day, during the procedure
Incidence of the use of neuromuscular blocking drugs
Time frame: 1 day, during the procedure
Incidence of emergency tracheostomy
Time frame: 1 day, during the procedure
Incidence of complications in SSPI and the complication rate on D1 after the panendoscopy procedure
Time frame: Through study completion, up to 2 days
Correlation between sedation dose and duration of non-hypoxemic apnea
Time frame: 1 day, during the procedure
Evaluation of the technique fluctuation
Time frame: 1 day, during the procedure
Operator satisfaction
Time frame: 1 day, after the procedure
Patient satisfaction
Time frame: up to 2 days
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 31 Mar 2026.
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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.
Pierre-Henri KOULMANN, MD principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Gas Delivery System in people with Head and Neck Cancer, run by Centre Antoine Lacassagne 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 6 inclusion and 21 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 31 Mar 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 arterial desaturation (time frame: 1 day, during the procédure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.