NCT05696288Completed
Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 11 Jan 2023
- Start date
- 12 Apr 2023
- Primary completion date
- 30 May 2025
- Lead sponsor
- Centre Antoine Lacassagne
- Diseases
- Head and neck cancer
- NCT number
- NCT05696288
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 12 Apr 2023 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with:
- A known intracranial pathology;
- Documented pulmonary hypertension;
- Uncontrolled epilepsy;
- Uncontrolled heart rhythm disorder;
- Pulmonary pathology with hypoxemia: Spo2 \<92% in ambient air;
- 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.
Other
- 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 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.