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Trial Title:
Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation
NCT ID:
NCT05696288
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
To compare the incidence of oxygen desaturation in patients ventilated with the Optiflow™
system to that of patients treated according to the standard technique.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Respiratory Gas Delivery System
Description:
Oxygen therapy during general anesthesia for ENT panendoscopy
Arm group label:
Arm A: investigational device (Respiratory Gas Delivery System)
Arm group label:
Arm B: standard nasal oxygenation device
Summary:
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.
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre Henri Koulmann, MD
Phone:
+33 492 031 456
Email:
pierre-henri.koulmann@nice.unicancer.fr
Contact backup:
Last name:
Sandrine CHELI, PhD
Phone:
+33 492 031 132
Email:
sandrine.cheli@nice.unicancer.fr
Start date:
April 12, 2023
Completion date:
June 12, 2025
Lead sponsor:
Agency:
Centre Antoine Lacassagne
Agency class:
Other
Source:
Centre Antoine Lacassagne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05696288
