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NCT Number: NCT05696288

Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne

Nice, 06189, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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:
  • 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.

Treatment and study plan

Respiratory Gas Delivery System

Procedure

Oxygen therapy during general anesthesia for ENT panendoscopy

Primary outcomes

  1. 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

Secondary outcomes

  1. Measure the non-hypoxemic apnea time

    Time frame: 1 day, during the procédure

    Non-hypoxemic apnea time will be measured as soon as the SpO2 parameter is between 100 and 95%

  2. Incidence of the use of manual ventilation

    Time frame: 1 day, during the procedure

    Interruption of the surgical procedure for use of manual ventilation with a facemask will be recorded.

  3. Incidence of the use of tracheal intubation

    Time frame: 1 day, during the procedure

    Conversion from the OHD oxygenation technique to the standard technique will be recorded

  4. Incidence of the use of neuromuscular blocking drugs

    Time frame: 1 day, during the procedure

    The use of neuromuscular blocking drugs will be recorded

  5. Incidence of emergency tracheostomy

    Time frame: 1 day, during the procedure

    The performance of an emergency tracheostomy will be recorded

  6. Incidence of complications in SSPI and the complication rate on D1 after the panendoscopy procedure

    Time frame: Through study completion, up to 2 days

    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.

  7. Correlation between sedation dose and duration of non-hypoxemic apnea

    Time frame: 1 day, during the procedure

    Correlation between the dose of sedation and the duration of non-hypoxemic apnea will be evaluated using Spearman's R coefficient

  8. Evaluation of the technique fluctuation

    Time frame: 1 day, during the procedure

    Hypoxic desaturation will be reported by acts and by technique

  9. Operator satisfaction

    Time frame: 1 day, after the procedure

    Operator's satisfaction will be noted at the end of each procedure using a visual analogic scale from 1 to 6

  10. Patient satisfaction

    Time frame: up to 2 days

    Patient satisfaction will be recorded using a scale from 1 to 6

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: OPTINOSE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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