ENT TumorNCT05601570
Impact of the Experience of Anaesthetists in Changing Ventilation Strategies During Panendoscopy on the Incidence of Intraoperative Hypoxaemia
An observational study of ENT Tumor, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
High Flow Nasal Oxygen Therapy (HFNO) is a new oxygenation tool that is becoming increasingly widespread in perioperative anaesthesia. The benefits of this oxygenation tool are based on different physiological principles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ENT Tumor
- How many people
- 850 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2024to 30 Oct 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: All major patients receiving panendoscopy during the period 2015 - 2020 in our center
Who may be able to join
- major patients receiving panendoscopy
Who cannot join
- panendoscopies performed in combination with another invasive procedure that may alter anaesthetic management
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Besançon
Besançon, Franche Comté, 25000
About this study
High Flow Nasal Oxygen Therapy (HFNO) is a new oxygenation tool that is becoming increasingly widespread in perioperative anaesthesia. The benefits of this oxygenation tool are based on different physiological principles. These include the reduction of dead space by "flushing" the nasopharyngeal cavities, positive airway pressure and the warming and humidification of inspired air. In addition, the high flow rates used ensure that the patient's inspiratory demand is covered, allowing for the delivery of oxygen-enriched and controlled air. It is simple to use, with the only parameters to be set being gas flow and FiO2. The use of HFNO appears to allow a prolongation of apnoea time without desaturation in apneic ventilation.
Mainly studied in ENT surgery because of the interest that this oxygenation strategy presents with the absence of recourse to oro-tracheal intubation (OTI), several authors will use it in the framework of micro-laryngoscopy surgery in suspension. However, its use as an oxygenation strategy during panendoscopy has been little explored. 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. Learning to use this new method or the impact of operator experience has never been explored.
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.
For several years, the strategy of oxygenation during panendoscopy and the number of practitioners performing this procedure has evolved in our centre.
- 2017, with the arrival of the HFNO in the operating room.
- 2020, during the SARS-CoV2 pandemic, changes in the organisation of the anaesthesiology department had to take place and the number of practitioners performing this procedure increased significantly.
The main objective of this study was to evaluate the impact of the evolution periods of the oxygenation strategies and the experience of the operators on the incidence of patients with at least one intra-procedural hypoxemia (SpO2 < 90% for more than one minute).
All patients who had a panendoscopy from 01 January 2015 to 31 December 2020 were analysed. The anaesthetists in our centre are divided into different practice specialties, so a small number of them regularly perform anaesthesia in ENT surgery. We divided the anaesthetists who performed panendoscopies during the study period into two categories in order to compare the incidence of severe hypoxaemia (SpO2 < 90%) among them :
- Experienced anaesthetists (practitioner who has performed at least 30 panendoscopies per year for two consecutive years)
- Non-experienced anaesthetists (practitioner who has performed at least one panendoscopy per year and does not meet the criteria for expertise)
- Conditions
- ENT Tumor
- Keywords
- Panendoscopy, High Flow Nasal Oxygen, face mask ventilation
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: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Secondary outcomes (4)
Proportion of patients within each of the ventilation modalities used in panendoscopies
Proportion of patients within each of the ventilation modalities used in panendoscopies Proportion of patients requiring repeat face mask ventilation (at least one reventilation outside the initial denitrogenation)
Measured: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Proportion of patients requiring oro-tracheal intubation
Proportion of patients intubated during panendoscopy
Duration of the procedure
Time (minutes) from induction of anaesthesia to discharge from the operating room
Measured: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Incidence of major intraoperative complications
Complications are : Extreme bradycardia < 30 beats per minute, hemodynamic instability defined by MAP < 40 mmHg, hypercapnia (more than 80 mmHg)
Measured: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start10 Apr 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion30 Oct 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 850 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
- NCT05601570
- Sponsor's protocol ID
- ID020621HFNO
- Status last verified
- Feb 2024
- First submitted
- 23 Oct 2022
- 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
- Impact of the Experience of Anaesthetists in Changing Ventilation Strategies During Panendoscopy on the Incidence of Intraoperative Hypoxaemia
- ClinicalTrials.gov ID
- NCT05601570
- Acronym / sponsor ID
- ID020621HFNO
- Conditions
- ENT Tumor
- Keywords
- Panendoscopy, High Flow Nasal Oxygen, face mask ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 1 Nov 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.
High Flow Nasal Oxygen Therapy (HFNO) is a new oxygenation tool that is becoming increasingly widespread in perioperative anaesthesia. The benefits of this oxygenation tool are based on different physiological principles. These include the reduction of dead space by "flushing" the nasopharyngeal cavities, positive airway pressure and the warming and humidification of inspired air. In addition, the high flow rates used ensure that the patient's inspiratory demand is covered, allowing for the delivery of oxygen-enriched and controlled air. It is simple to use, with the only parameters to be set being gas flow and FiO2. The use of HFNO appears to allow a prolongation of apnoea time without desaturation in apneic ventilation.
Mainly studied in ENT surgery because of the interest that this oxygenation strategy presents with the absence of recourse to oro-tracheal intubation (OTI), several authors will use it in the framework of micro-laryngoscopy surgery in suspension. However, its use as an oxygenation strategy during panendoscopy has been little explored. 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. Learning to use this new method or the impact of operator experience has never been explored.
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.
For several years, the strategy of oxygenation during panendoscopy and the number of practitioners performing this procedure has evolved in our centre.
- 2017, with the arrival of the HFNO in the operating room.
- 2020, during the SARS-CoV2 pandemic, changes in the organisation of the anaesthesiology department had to take place and the number of practitioners performing this procedure increased significantly.
The main objective of this study was to evaluate the impact of the evolution periods of the oxygenation strategies and the experience of the operators on the incidence of patients with at least one intra-procedural hypoxemia (SpO2 < 90% for more than one minute).
All patients who had a panendoscopy from 01 January 2015 to 31 December 2020 were analysed. The anaesthetists in our centre are divided into different practice specialties, so a small number of them regularly perform anaesthesia in ENT surgery. We divided the anaesthetists who performed panendoscopies during the study period into two categories in order to compare the incidence of severe hypoxaemia (SpO2 < 90%) among them :
- Experienced anaesthetists (practitioner who has performed at least 30 panendoscopies per year for two consecutive years)
- Non-experienced anaesthetists (practitioner who has performed at least one panendoscopy per year and does not meet the criteria for expertise)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All major patients receiving panendoscopy during the period 2015 - 2020 in our center
Key inclusion criteria (1 listed)
- major patients receiving panendoscopy
Key exclusion criteria (1 listed)
- panendoscopies performed in combination with another invasive procedure that may alter anaesthetic management
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: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Proportion of patients with oxygen desaturation (SpO2 < 90%) for more than 1 minute.
4 secondary outcomes
Proportion of patients within each of the ventilation modalities used in panendoscopies
Time frame: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Proportion of patients requiring oro-tracheal intubation
Duration of the procedure
Time frame: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
Incidence of major intraoperative complications
Time frame: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre
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 1 inclusion and 1 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: during the intervention (max 6hours)from induction of anaesthesia to discharge from the operating theatre). 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.