High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General Anesthesia

NCT03472118 | Terminated

• 1 other identifier: 2018/04
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

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

  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

  throughout surgery (maximum thirty minutes)

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

  throughout surgery (maximum thirty minutes)

• Incidence of hypercapnia (PaCO2>60mmHg) at the end of surgery or at technique failure

  At the end of surgery (maximum thirty minutes) or at technique failure (upon blood oxygen desaturation SpO2<92%)

Study Arms (1)

High Flow Apneic Oxygenation

EXPERIMENTAL

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

Device: Nasal High Flow Oxygen

Interventions

Nasal High Flow Oxygen DEVICE

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

High Flow Apneic Oxygenation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Epilepsy
• Arrhythmia
• Pulmonary hypertension
• Lung disease with basal SpO2\<95%
• Obstructive laryngeal tumor
• BMI\>30kg.m-2

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (2)

Hôpital René Huguenin - Institut Curie

Saint-Cloud, Île-de-France Region, 92310, France

Location

Hôpital Foch

Suresnes, Île-de-France Region, 92151, France

Location

Related Publications (1)

• 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.

  PMID: 36524243 RESULT

MeSH Terms

Conditions

Apnea; Acidosis, Respiratory; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Mary SAAD, MD

  Institut Curie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: July 5, 2018
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)