LaryngoscopyOxALaNCT03472118
High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General Anesthesia
A study testing Nasal High Flow Oxygen in people with Laryngoscopy and Apnea, run by CMC Ambroise Paré at 2 sites in France.
Trial summary
Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered to their lungs through different methods. Inserting a tube in the trachea is the best means for oxygen delivery. However, it does not allow for optimal visibility of the operated area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngoscopy, Apnea, Anesthesia
- What is being tested?
- Nasal High Flow Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jul 2018to 24 Jan 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 years and older
- 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 undergoing any suspension laryngoscopy other than laser surgery and cavoscopy and expected to last less than 30 minutes
Who cannot join
- Pregnancy
- Epilepsy
- Arrhythmia
- Pulmonary hypertension
- Lung disease with basal SpO2<95%
- Obstructive laryngeal tumor
- BMI>30kg.m-2
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital René Huguenin - Institut Curie
Saint-Cloud, Île-de-France Region, 92310
Hôpital Foch
Suresnes, Île-de-France Region, 92151
About this study
Official title: Apneic Oxygenation Using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Adult Patients Undergoing Suspension Laryngoscopy Under General Anesthesia: a Multicenter Study
Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered to their lungs through different methods. Inserting a tube in the trachea is the best means for oxygen delivery. However, it does not allow for optimal visibility of the operated area. Other techniques can be used but have disadvantages with some being associated with serious complications. No consensus exists regarding the best airway management technique for this intervention.
The aim of the study is to investigate a new device that delivers oxygen at very high flow through a nasal cannula in patients undergoing suspension laryngoscopy under general anaesthesia. This technique allows the surgeon to have a perfect visualisation of the laryngeal structures while allowing the delivery of oxygen for the lungs.
Read more
After informed consent, adult patients undergoing suspension laryngoscopy under general anaesthesia in two French hospitals will receive high flow oxygen throughout the procedure. At the end of surgery or, whenever applicable, at the time of technique failure (with a decrease in blood oxygen saturation to less than 92%), blood will be drawn for analysis. All patients will have a thin security catheter inserted in their trachea (the currently used technique in both participating hospitals), allowing for rescue high frequency ventilation if ever the study technique fails.
The safety of the device will also be assessed by analysing the blood samples for signs of carbon dioxide accumulation and by collecting any intra or post-operative complications.
If the device shows to be effective at maintaining blood oxygenation without significant associated risks, it could be used for other surgical situations where airway management is expected to be difficult.
Read the detailed description
Suspension laryngoscopy is a surgical intervention for which no airway management recommendations exist.
Many techniques are used, each having limitations. While tracheal intubation is the gold standard of airway management, in this particular intervention, it does not allow for optimal visualisation of the larynx. Maintaining spontaneous ventilation under general anaesthesia is used by some teams but puts the patient at the risk of laryngospasm. Apneic oxygenation is another option but its use is limited by the associated risk of hypercapnia. High frequency jet ventilation allows for good surgical conditions, satisfactory blood oxygen delivery and a low risk of hypercapnia; however, its use has been associated with severe, sometimes deadly, complications.
Nasal High Flow oxygenation is a relatively novel technique that allows for the delivery of heated and humidified oxygen with flow ranging up to 70l/min. It is widely used in neonatal and adult critical care. Its use in apneic patients under general anaesthesia has been reported to be associated with a mean of 14 minutes of desaturation-free apnea time with limited risk of hypercapnia. Desaturation-free apnea times up to 60 minutes have been reported. The use of nasal high flow apneic oxygenation in suspension laryngoscopy has been reported once in the literature with encouraging results.
The aim of the study is to assess the efficacy of nasal high flow oxygen in maintaining normal blood oxygen saturation (>95%) in apneic patients undergoing suspension laryngoscopy under general anaesthesia.
Adult patients undergoing suspension laryngoscopy (laser surgeries and cavoscopies excluded) in two french hospitals will be screened for eligibility by the anaesthesiologist during the preoperative consultation. Consenting and eligible patients will be enrolled in the study.
After pre oxygenation (until etO2 >90%), general anaesthesia will be started and maintained using TIVA propofol and remifentanil. Neuromuscular blockade will be achieved using rocuronium.
As soon as apnea is obtained, nasal high flow oxygen will be started at 70l/min using Simplified OptiflowTM (Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand) . A transglottic high frequency jet ventilation catheter will also be placed in the trachea to allow for emergency ventilation if high flow oxygenation fails to maintain SpO2>92%.
Oxygen saturation, blood pressure, pulse rate, BIS and neuromuscular blockade will be monitored throughout the surgery.
At the end of surgery (maximum 30 minutes), or as soon as blood oxygen saturation falls below 92%, whichever comes first, arterial blood for blood-gas analysis (PaO2, PaCO2, pH) will be drawn.
Neuromuscular blockade will be reversed with neostigmine or sugammadex depending on the depth of nerve block.
If the technique is shown to be associated with a low risk of blood oxygen desaturation and of severe hypercapnia, it could be considered for predictable difficult airway management.
- Conditions
- Laryngoscopy, Apnea, Anesthesia
- Being tested
- Nasal High Flow Oxygen
- Keywords
- Anesthesia, general, Adult, Humans, Apnea, Oxygen, Carbon dioxide, Acidosis, respiratory, Administration, Intranals/methods, Airway management/methods, Continuous positive airway pressure/methods, Insufflation/methods, Oxygen/administration&dosage, Laryngoscopy, Larynx/surgery
- Medical subject headings
- Apnea, Acidosis, Respiratory, Laryngeal Diseases
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 during apnoea using Optiflow device of Fisher and Paykel
| Study group | Role | What they receive |
|---|---|---|
| High Flow Apneic Oxygenation | Experimental | Apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Receives: Device: Nasal High Flow Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oxygen desaturation SpO2<95% in the first fifteen minutes of apnea in patients undergoing suspension laryngoscopy under general anesthesia and receiving nasal high flow oxygen
Measured: throughout the first fifteen minutes following the start of apnea, ie following general anesthesia and neuromuscular blockade
Secondary outcomes (3)
Incidence of oxygen desaturation SpO2<95% throughout surgery
Measured: throughout surgery (maximum thirty minutes)
Duration between start of apnea and oxygen desaturation spO2<95%
Measured: throughout surgery (maximum thirty minutes)
Incidence of hypercapnia (PaCO2>60mmHg) at the end of surgery or at technique failure
Measured: At the end of surgery (maximum thirty minutes) or at technique failure (upon blood oxygen desaturation SpO2<92%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start5 Jul 2018
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Why it stopped: Risk-benefit analysis
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 LaryngoscopyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary SAAD, MD, Study chair, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472118
- Sponsor's protocol ID
- 2018/04
- Acronym
- OxALa
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saad M, Albi-Feldzer A, Taouachi R, Wagner I, Fischler M, Squara P, Le Guen M. High-flow nasal oxygen for suspension laryngoscopy: a multicenter open-label study. J Int Med Res. 2022 Dec;50(12):3000605221140685. doi: 10.1177/03000605221140685.
PubMed 36524243
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
- Apneic Oxygenation Using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Adult Patients Undergoing Suspension Laryngoscopy Under General Anesthesia: a Multicenter Study
- ClinicalTrials.gov ID
- NCT03472118
- Acronym / sponsor ID
- OxALa / 2018/04
- Conditions
- Laryngoscopy, Apnea, Anesthesia
- Keywords
- Anesthesia, general, Adult, Humans, Apnea, Oxygen, Carbon dioxide, Acidosis, respiratory, Administration, Intranals/methods
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Risk-benefit analysis
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 21 Mar 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.
Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered to their lungs through different methods. Inserting a tube in the trachea is the best means for oxygen delivery. However, it does not allow for optimal visibility of the operated area. Other techniques can be used but have disadvantages with some being associated with serious complications. No consensus exists regarding the best airway management technique for this intervention.
The aim of the study is to investigate a new device that delivers oxygen at very high flow through a nasal cannula in patients undergoing suspension laryngoscopy under general anaesthesia. This technique allows the surgeon to have a perfect visualisation of the laryngeal structures while allowing the delivery of oxygen for the lungs.
After informed consent, adult patients undergoing suspension laryngoscopy under general anaesthesia in two French hospitals will receive high flow oxygen throughout the procedure. At the end of surgery or, whenever applicable, at the time of technique failure (with a decrease in blood oxygen saturation to less than 92%), blood will be drawn for analysis. All patients will have a thin security catheter inserted in their trachea (the currently used technique in both participating hospitals), allowing for rescue high frequency ventilation if ever the study technique fails.
The safety of the device will also be assessed by analysing the blood samples for signs of carbon dioxide accumulation and by collecting any intra or post-operative complications.
If the device shows to be effective at maintaining blood oxygenation without significant associated risks, it could be used for other surgical situations where airway management is expected to be difficult.
Detailed description
Suspension laryngoscopy is a surgical intervention for which no airway management recommendations exist.
Many techniques are used, each having limitations. While tracheal intubation is the gold standard of airway management, in this particular intervention, it does not allow for optimal visualisation of the larynx. Maintaining spontaneous ventilation under general anaesthesia is used by some teams but puts the patient at the risk of laryngospasm. Apneic oxygenation is another option but its use is limited by the associated risk of hypercapnia. High frequency jet ventilation allows for good surgical conditions, satisfactory blood oxygen delivery and a low risk of hypercapnia; however, its use has been associated with severe, sometimes deadly, complications.
Nasal High Flow oxygenation is a relatively novel technique that allows for the delivery of heated and humidified oxygen with flow ranging up to 70l/min. It is widely used in neonatal and adult critical care. Its use in apneic patients under general anaesthesia has been reported to be associated with a mean of 14 minutes of desaturation-free apnea time with limited risk of hypercapnia. Desaturation-free apnea times up to 60 minutes have been reported. The use of nasal high flow apneic oxygenation in suspension laryngoscopy has been reported once in the literature with encouraging results.
The aim of the study is to assess the efficacy of nasal high flow oxygen in maintaining normal blood oxygen saturation (>95%) in apneic patients undergoing suspension laryngoscopy under general anaesthesia.
Adult patients undergoing suspension laryngoscopy (laser surgeries and cavoscopies excluded) in two french hospitals will be screened for eligibility by the anaesthesiologist during the preoperative consultation. Consenting and eligible patients will be enrolled in the study.
After pre oxygenation (until etO2 >90%), general anaesthesia will be started and maintained using TIVA propofol and remifentanil. Neuromuscular blockade will be achieved using rocuronium.
As soon as apnea is obtained, nasal high flow oxygen will be started at 70l/min using Simplified OptiflowTM (Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand) . A transglottic high frequency jet ventilation catheter will also be placed in the trachea to allow for emergency ventilation if high flow oxygenation fails to maintain SpO2>92%.
Oxygen saturation, blood pressure, pulse rate, BIS and neuromuscular blockade will be monitored throughout the surgery.
At the end of surgery (maximum 30 minutes), or as soon as blood oxygen saturation falls below 92%, whichever comes first, arterial blood for blood-gas analysis (PaO2, PaCO2, pH) will be drawn.
Neuromuscular blockade will be reversed with neostigmine or sugammadex depending on the depth of nerve block.
If the technique is shown to be associated with a low risk of blood oxygen desaturation and of severe hypercapnia, it could be considered for predictable difficult airway management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Flow Apneic Oxygenation | Experimental | Device: Nasal High Flow OxygenApneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) |
Who may qualify
- Ages
- 18 years and older
- 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 undergoing any suspension laryngoscopy other than laser surgery and cavoscopy and expected to last less than 30 minutes
Key exclusion criteria (7 listed)
- Pregnancy
- Epilepsy
- Arrhythmia
- Pulmonary hypertension
- Lung disease with basal SpO2<95%
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 during apnoea using Optiflow device of Fisher and Paykel | Device | High Flow Apneic Oxygenation |
Primary outcome
Incidence of oxygen desaturation SpO2<95% in the first fifteen minutes of apnea in patients undergoing suspension laryngoscopy under general anesthesia and receiving nasal high flow oxygen
Time frame: throughout the first fifteen minutes following the start of apnea, ie following general anesthesia and neuromuscular blockade
3 secondary outcomes
Incidence of oxygen desaturation SpO2<95% throughout surgery
Time frame: throughout surgery (maximum thirty minutes)
Duration between start of apnea and oxygen desaturation spO2<95%
Time frame: throughout surgery (maximum thirty minutes)
Incidence of hypercapnia (PaCO2>60mmHg) at the end of surgery or at technique failure
Time frame: At the end of surgery (maximum thirty minutes) or at technique failure (upon blood oxygen desaturation SpO2<92%)
Results and safety
The study was stopped early (reason given: Risk-benefit analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 36524243Saad M, Albi-Feldzer A, Taouachi R, Wagner I, Fischler M, Squara P, Le Guen M. High-flow nasal oxygen for suspension laryngoscopy: a multicenter open-label study. J Int Med Res. 2022 Dec;50(12):3000605221140685. doi: 10.1177/03000605221140685.
- 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.
Mary SAAD, MD study chair
Institut Curie
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 in people with Laryngoscopy and Apnea, 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 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: stopped early, 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 was stopped early (reason given: Risk-benefit analysis). Results are not available in the source record.
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 oxygen desaturation SpO2<95% in the first fifteen minutes of apnea in patients undergoing suspension laryngoscopy under general anesthesia and receiving nasal high flow oxygen (time frame: throughout the first fifteen minutes following the start of apnea, ie following general anesthesia and neuromuscular blockade). 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 NCT03472118, 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.