ClinicalTrials.gg
TerminatedNCT03472118OxALaUpdated Apr 8, 2026

High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General Anesthesia

An interventional study of Nasal High Flow Oxygen in Laryngoscopy, Apnea and Anesthesia, sponsored by CMC Ambroise Paré. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Treatment

Why this study was terminated
Risk-benefit analysis

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Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 19 studies in Apnea with a site in France — 2 open to participants now, 3 under way, none of them phase 3. Apnea · France.

Enrollment
10th of 14
29 · median 64
Started
2018
with 1 other
No phase
12 of 19
1 open now
Registered
12th of 19
by date
Lead sponsor
1 of 19
CMC Ambroise Paré

Among the 19 studies in Apnea with a site in France, this one is the 10th largest by enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2018, is one of 12 with no phase, and was the 12th registered.

Apnea

282 studies on the registry are indexed under Apnea; 54 are open to participants now.

Browse Apnea studies →

Open to participants now

2 of the 19 studies in Apnea with a site in France are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 40 Apnea studies recruiting now, 9 (23%) set no upper age limit and 27 (68%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

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.

03

Conditions studied

  • Laryngoscopy
  • Apnea
  • Anesthesia

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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Epilepsy
  • Arrhythmia
  • Pulmonary hypertension
  • Lung disease with basal SpO2\<95%
  • Obstructive laryngeal tumor
  • >30kg.m-2
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    High Flow Apneic Oxygenation

    Apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE)

    Device: Nasal High Flow Oxygen

Interventions

  • DeviceNasal High Flow Oxygen

    Nasal High Flow Oxygen during apnoea using Optiflow device of Fisher and Paykel

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of oxygen desaturation SpO2<95% throughout surgery

    Time frame: throughout surgery (maximum thirty minutes)

  2. Duration between start of apnea and oxygen desaturation spO2<95%

    Time frame: throughout surgery (maximum thirty minutes)

  3. 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%)

07

Study locations

2 sites
  • Hôpital René Huguenin - Institut Curie
    Saint-Cloud, Île-de-France Region 92310, France
  • Hôpital Foch
    Suresnes, Île-de-France Region 92151, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2018 to primary completion in Jan 2019, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2018
First posted
Mar 21, 2018
StartActual
Jul 5, 2018
Primary completionActual
Jan 24, 2019
CompletionActual
Jan 24, 2019
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03472118
Lead sponsor
CMC Ambroise Paré
Responsible party
Sponsor
First posted
Mar 21, 2018
Start date
Jul 5, 2018
Primary completion
Jan 24, 2019
Completion
Jan 24, 2019
Last update
Apr 8, 2026

Study contacts

Mary SAAD, MD
study chair · Institut Curie

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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