Comparison of HFNO and FMV on Desaturations During Panendoscopy Under General Anesthesia

Comparison of High-flow Nasal Oxygen Therapy and Face Mask Ventilation on Desaturations During Panendoscopy Under General Anesthesia

Panendoscopy is a common procedure that requires deep and short anesthesia. The main challenge is the sharing of the airway between the anesthesia team and the surgical team. There are several methods to ensure oxygenation during this type of procedure: oro-tracheal intubation, jet ventilation, spontaneous ventilation anesthesia, apneic ventilation with intermittent face mask ventilation. There is no consensus regarding the best airway management technique for this procedure. Regardless of the method chosen to ensure oxygenation during this procedure, the risk of hypoxemia during desaturation episodes is significant.

However, the use of HFNO seems to show a prolongation of apnea time without desaturations (< 90% SpO2) and seems to allow the performance of panendocoscopies.

In the Besançon University Hospital, since 2017, all panendoscopies are performed with HFNO. Before 2017, panendoscopies were performed under face mask ventilation. The main of the study hypothesis is that HFNO brought a gain in terms of safety, especially on the desaturation rate compared to face mask ventilation.

The investigators will carry out a quasi-experimental study comparing two periods. The first period concerns the years 2015-2016. It aims to study patients who had panendoscopies performed under FMV. The second period covers the years 2018-2019. It aims to study patients who had panendoscopies performed under HFNO.

The year 2017 is considered as the washout period necessary to avoid the learning effect of the HFNO introduced during that year.

Study Overview

• Status: Not yet recruiting
• Conditions: ENT Tumor

Detailed Description

Currently, there are several strategies to ensure oxygenation during this specific type of ENT management:

• Mechanical ventilation with oro-tracheal intubation (OTI)
• face mask ventilation (FMV)
• Jet ventilation
• HFNO Each of these methods has advantages and disadvantages, which explains why there are no clear recommendations to date on the preferred anesthesia and oxygenation technique. Regardless of the method chosen, the risks remain significant for the patient, particularly the risk of hypoxemia during a desaturation episode.

In 2017, HFNO was introduced for panendoscopies in the Besançon University Hospital. Before 2017, panendoscopies were mainly perfomed with intermittent face mask ventilation.

The objective of the study is to compare the FMV group (patients receiving panendoscopy and ventilated with FMV during 2015-2016) with the HFNO group (patients receiving panendoscopy and oxygenated with HFNO during 2018-2019) with respect to perprocedural hypoxemia (SpO2<90% for more than 1 minute).

Secondary objectives are to compare complications, use of oro-tracheal intubation, and procedure duration between the two oxygenation methods.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: David Ferreira, MD, PhD; Phone Number: +33642841108; Email: dferreira@chu-besancon.fr

Study Locations

• France
  • Franche Comté
    • Besançon, Franche Comté, France, 25000
      • CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Face Mask Ventilation (FMV) Group :patients who had panendoscopies performed under FMV during the years 2015-2016.

HFNO group :patients who had panendoscopies performed under HFNO during the years the years 2018-2019.

Description

Inclusion Criteria:

• major patients receiving panendoscopy
• patients ventilated by face mask during the first period,
• patients receiving oxygen by HFNO during the second period

Exclusion Criteria:

• Patients receiving ventilatory strategy other than those selected by time period.
• Patients receiving panendoscopies performed with a method of oxygenation other than those defined in their period.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
FaceMask Ventilation (FMV); During the period from January 1, 2015, to December 31, 2016, all panendoscopies performed with FMV, whether urgent or scheduled and regardless of indication, were included. Panendoscopies performed with any other oxygenation method were excluded.
HFNO; During the period from January 1, 2018, to December 31, 2019, all panendoscopies performed with HFNO, urgent or scheduled and regardless of indication, were included. Panendoscopies performed with any other oxygenation method were excluded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with oxygen desaturation	Proportion of patients with oxygen desaturation (SpO2 < 90%) for more than 1 minute.	more than 1 minute during the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients requiring repeat face mask ventilation	Proportion of patients requiring repeat face mask ventilation (at least one reventilation outside the initial denitrogenation)	more than 1 minute during the intervention
Proportion of patients requiring oro-tracheal intubation	Proportion of patients intubated during panendoscopy	during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Duration of the procedure	Time (minutes) from induction of anaesthesia to discharge from the operating theatre	during the intervention (max 6hours) from induction of anaesthesia to discharge from the operating theatre
Incidence of mild intraoperative complications	Complications are : mild bradycardia (between 45 and 30 beats per minute), hypotension defined by MAP (between 65 and 40mmHg), hypercapnia (betaween 60 and 80 mmHg)	more than 1 minute during the intervention
Incidence of major intraoperative complications	Complications are : Tracheotomy, extreme bradycardia < 30 beats per minute, hemodynamic instability defined by MAP < 40mmHg, hypercapnia (more than 80 mmHg)	more than 1 minute during the intervention

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: desaturation; nasal high flow oxygen therapy; Panendoscopy; face mask ventilation
• Other Study ID Numbers: ID052021HFNO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No