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

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Respiratory Gas Delivery System
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: investigational device (Respiratory Gas Delivery System)

Arm B: standard nasal oxygenation device

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of arterial desaturation
The O2 saturation defined as SpO2 <95% will be collected each time it reaches 94% or less

Secondary Outcome Measures

Measure the non-hypoxemic apnea time
Non-hypoxemic apnea time will be measured as soon as the SpO2 parameter is between 100 and 95%
Incidence of the use of manual ventilation
Interruption of the surgical procedure for use of manual ventilation with a facemask will be recorded.
Incidence of the use of tracheal intubation
Conversion from the OHD oxygenation technique to the standard technique will be recorded
Incidence of the use of neuromuscular blocking drugs
The use of neuromuscular blocking drugs will be recorded
Incidence of emergency tracheostomy
The performance of an emergency tracheostomy will be recorded
Incidence of complications in SSPI and the complication rate on D1 after the panendoscopy procedure
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.
Correlation between sedation dose and duration of non-hypoxemic apnea
Correlation between the dose of sedation and the duration of non-hypoxemic apnea will be evaluated using Spearman's R coefficient
Evaluation of the technique fluctuation
Hypoxic desaturation will be reported by acts and by technique
Operator satisfaction
Operator's satisfaction will be noted at the end of each procedure using a visual analogic scale from 1 to 6
Patient satisfaction
Patient satisfaction will be recorded using a scale from 1 to 6

Full Information

First Posted
January 11, 2023
Last Updated
April 13, 2023
Sponsor
Centre Antoine Lacassagne
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1. Study Identification

Unique Protocol Identification Number
NCT05696288
Brief Title
Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation
Acronym
OPTINOSE
Official Title
Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
April 12, 2025 (Anticipated)
Study Completion Date
June 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: investigational device (Respiratory Gas Delivery System)
Arm Type
Experimental
Arm Description
Patients ventilated with the Optiflow™ system, a nasal high flow oxygenation system (NHFO) while undergoing a panendoscopy
Arm Title
Arm B: standard nasal oxygenation device
Arm Type
Active Comparator
Arm Description
Patients ventilated according to the standard technique while undergoing a panendoscopy
Intervention Type
Procedure
Intervention Name(s)
Respiratory Gas Delivery System
Intervention Description
Oxygen therapy during general anesthesia for ENT panendoscopy
Primary Outcome Measure Information:
Title
Incidence of arterial desaturation
Description
The O2 saturation defined as SpO2 <95% will be collected each time it reaches 94% or less
Time Frame
1 day, during the procédure
Secondary Outcome Measure Information:
Title
Measure the non-hypoxemic apnea time
Description
Non-hypoxemic apnea time will be measured as soon as the SpO2 parameter is between 100 and 95%
Time Frame
1 day, during the procédure
Title
Incidence of the use of manual ventilation
Description
Interruption of the surgical procedure for use of manual ventilation with a facemask will be recorded.
Time Frame
1 day, during the procedure
Title
Incidence of the use of tracheal intubation
Description
Conversion from the OHD oxygenation technique to the standard technique will be recorded
Time Frame
1 day, during the procedure
Title
Incidence of the use of neuromuscular blocking drugs
Description
The use of neuromuscular blocking drugs will be recorded
Time Frame
1 day, during the procedure
Title
Incidence of emergency tracheostomy
Description
The performance of an emergency tracheostomy will be recorded
Time Frame
1 day, during the procedure
Title
Incidence of complications in SSPI and the complication rate on D1 after the panendoscopy procedure
Description
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.
Time Frame
Through study completion, up to 2 days
Title
Correlation between sedation dose and duration of non-hypoxemic apnea
Description
Correlation between the dose of sedation and the duration of non-hypoxemic apnea will be evaluated using Spearman's R coefficient
Time Frame
1 day, during the procedure
Title
Evaluation of the technique fluctuation
Description
Hypoxic desaturation will be reported by acts and by technique
Time Frame
1 day, during the procedure
Title
Operator satisfaction
Description
Operator's satisfaction will be noted at the end of each procedure using a visual analogic scale from 1 to 6
Time Frame
1 day, after the procedure
Title
Patient satisfaction
Description
Patient satisfaction will be recorded using a scale from 1 to 6
Time Frame
up to 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Henri KOULMANN, MD
Phone
+33 492 031 456
Email
pierre-henri.koulmann@nice.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Henri KOULMANN, MD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Henri Koulmann, MD
Phone
+33 492 031 456
Email
pierre-henri.koulmann@nice.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sandrine CHELI, PhD
Phone
+33 492 031 132
Email
sandrine.cheli@nice.unicancer.fr

12. IPD Sharing Statement

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

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