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Trial Title:
Comparison of HFNO and FMV on Desaturations During Panendoscopy Under General Anesthesia
NCT ID:
NCT05593718
Condition:
ENT Tumor
Conditions: Keywords:
Panendoscopy
nasal high flow oxygen therapy
face mask ventilation
desaturation
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire de Besançon
Address:
City:
Besançon
Zip:
25000
Country:
France
Start date:
October 20, 2024
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Besancon
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Besancon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05593718
