ENT TumorNCT05593718
Comparison of HFNO and FMV on Desaturations During Panendoscopy Under General Anesthesia
An observational study of ENT Tumor, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ENT Tumor
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- major patients receiving panendoscopy
- patients ventilated by face mask during the first period,
- patients receiving oxygen by HFNO during the second period
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Besançon
Besançon, Franche Comté, 25000
About this study
Official title: 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.
Read more
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.
Read the 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
- Keywords
- Panendoscopy, nasal high flow oxygen therapy, face mask ventilation, desaturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with oxygen desaturation
Proportion of patients with oxygen desaturation (SpO2 < 90%) for more than 1 minute.
Measured: more than 1 minute during the intervention
Secondary outcomes (5)
Proportion of patients requiring repeat face mask ventilation
Proportion of patients requiring repeat face mask ventilation (at least one reventilation outside the initial denitrogenation)
Measured: more than 1 minute during the intervention
Proportion of patients requiring oro-tracheal intubation
Proportion of patients intubated during panendoscopy
Measured: 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
Measured: 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)
Measured: 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)
Measured: more than 1 minute during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start20 Oct 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENT TumorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ferreira, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593718
- Sponsor's protocol ID
- ID052021HFNO
- Status last verified
- Feb 2024
- First submitted
- 31 May 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-flow Nasal Oxygen Therapy and Face Mask Ventilation on Desaturations During Panendoscopy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05593718
- Acronym / sponsor ID
- ID052021HFNO
- Conditions
- ENT Tumor
- Keywords
- Panendoscopy, nasal high flow oxygen therapy, face mask ventilation, desaturation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- major patients receiving panendoscopy
- patients ventilated by face mask during the first period,
- patients receiving oxygen by HFNO during the second period
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with oxygen desaturation
Time frame: more than 1 minute during the intervention
Proportion of patients with oxygen desaturation (SpO2 < 90%) for more than 1 minute.
5 secondary outcomes
Proportion of patients requiring repeat face mask ventilation
Time frame: more than 1 minute during the intervention
Proportion of patients requiring oro-tracheal intubation
Time frame: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Duration of the procedure
Time frame: during the intervention (max 6hours) from induction of anaesthesia to discharge from the operating theatre
Incidence of mild intraoperative complications
Time frame: more than 1 minute during the intervention
Incidence of major intraoperative complications
Time frame: more than 1 minute during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ENT Tumor, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Ferreira, MD, PhD (+33642841108, dferreira@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with oxygen desaturation (time frame: more than 1 minute during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.