Comparing oxygen therapies for head and neck cancer procedures

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

This study tests whether a new high-flow oxygen therapy can make it safer for adults with head and neck cancer during a common procedure called panendoscopy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Antoine Lacassagne (other)
• Locations: 1 site (Nice)
• Trial ID: NCT05696288 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of high-flow oxygen therapy using the THRIVE system compared to conventional oxygen therapy during diagnostic panendoscopy under general anesthesia in patients with head and neck cancer. The study aims to enhance patient safety by allowing longer safe apnea times and reducing complications associated with airway management. Researchers will evaluate the outcomes of patients undergoing this common ENT procedure to determine if high-flow oxygen should be the standard practice. The trial includes patients over 18 years old with specific eligibility criteria related to their health and cancer status.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with head and neck cancer requiring diagnostic panendoscopy and who meet specific health criteria.

Not a fit: Patients with severe airway obstruction, certain intracranial pathologies, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve patient safety during ENT procedures by establishing a new standard for oxygen delivery.

How similar studies have performed: While there is growing interest in high-flow oxygen therapies, this specific approach for ENT panendoscopy is novel and has not been widely tested.

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.

Where this trial is running

Nice

• Centre Antoine Lacassagne — Nice, France (RECRUITING)

Study contacts

• Principal investigator: Pierre-Henri KOULMANN, MD — Centre Antoine Lacassagne
• Study coordinator: Pierre-Henri KOULMANN, MD

Conditions: Head and Neck Cancer