Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation (OPTINOSE)
Head and Neck Cancer
About this trial
This is an interventional prevention trial for Head and Neck Cancer
Eligibility Criteria
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.
Sites / Locations
- Centre Antoine LacassagneRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A: investigational device (Respiratory Gas Delivery System)
Arm B: standard nasal oxygenation device
Patients ventilated with the Optiflow™ system, a nasal high flow oxygenation system (NHFO) while undergoing a panendoscopy
Patients ventilated according to the standard technique while undergoing a panendoscopy