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

NCT ID: NCT05593718

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2024-11-30

Brief Summary

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.

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.

Conditions

ENT Tumor

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

David Ferreira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier Universitaire de Besançon

Besançon, Franche Comté, France

Countries

France

Central Contacts

David Ferreira, MD, PhD

Role: CONTACT

dferreira@chu-besancon.fr

+33642841108

Other Identifiers

ID052021HFNO

Identifier Type: -

Identifier Source: org_study_id