Laryngeal DiseaseVentinova ORLNCT04369040
Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery
A study testing High-flow nasal oxygen therapy using a specific nasal cannula in people with Laryngeal Disease, run by Hopital Foch at 1 site in France.
Trial summary
Single-center, randomized study, comparing two methods of oxygenation on 80 patients Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Laryngeal Disease
- What is being tested?
- High-flow nasal oxygen therapy using a specific nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2022to 18 Jul 2022
- Phase
- Interventional
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over the age of 18 and under the age of 80
- Patient to benefit from micro-laryngeal ENT surgery under general anesthesia and myorelaxation with an estimated duration which does not exceed 30 minutes
- Having signed a consent form
- Being affiliated with a Health Insurance plan.
Who cannot join
- Pregnant or lactating patient
- Patient with a weight <40 kg
- Obese patient (BMI> 30)
- Patient with foreseeable intubation difficulty
- Patient maintained under general anesthesia postoperatively
- Surgery requiring time by surgical laser
Show all 9Show fewer
- Surgery involving the use of an active electrosurgical electrode in the immediate area of the electrosurgical device or electrode
- Predictable surgery longer than 30 minutes
- Being deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Ventilation Systems in Laryngeal Surgery: High-flow Nasal Oxygen Therapy and Laryngeal Micro-catheter With the Ventinova Technique
Single-center, randomized study, comparing two methods of oxygenation on 80 patients
Read the detailed description
This study is a single-center, randomized study, comparing two methods of oxygenation during micro-laryngeal surgery performed under general anesthesia and myorelaxation: high-flow nasal oxygen therapy (HFNO) or Flow Controlled Ventilation (FCV) using a laryngeal tri-tube. The study population will be composed of 80 patients, aged over 18 and under 80.
- Conditions
- Laryngeal Disease
- Being tested
- High-flow nasal oxygen therapy using a specific nasal cannula, Flow Controlled Ventilation using a laryngeal tri-tube
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal oxygen therapy using a specific nasal cannulaDevice
Patient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery
Flow Controlled Ventilation using a laryngeal tri-tubeDevice
Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal oxygen therapy | Other | Ventilation with High-flow nasal oxygen therapy Receives: Device: High-flow nasal oxygen therapy using a specific nasal cannula |
| Flow Controlled Ventilation | Experimental | Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique Receives: Device: Flow Controlled Ventilation using a laryngeal tri-tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the percentage of patients having oxygen desaturation during the procedure or a PaCO2 > 65 mmHg at its end with both methods (high-flow nasal oxygen therapy and the use of FCV modality via a laryngeal tri-tube).
% of patients having an oxygen desaturation (SpO2<92%) during the procedure OR a PaCO2 > 65 mmHg at its end
Measured: 1 day (during surgery)
Secondary outcomes (8)
Evaluate the duration of oxygen therapy before desaturation in the two groups
Delay before oxygen desaturation (SpO2<92%) during the procedure
Measured: 1 day (during surgery)
Evaluate the quality of the visualization of the laryngeal region in the two groups
Percentage of glottic opening (POGO) score at laryngoscopy
Measured: 1 day (during surgery)
Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques
PaCO2 (partial pressure of carbon dioxide) at the end of the procedure
Measured: 1 day (during surgery)
Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)
Minimal inspired fraction of oxygen during the procedure
Measured: 1 day (during surgery)
Evaluate the incidence of atelectasis
Incidence of atelectasis on a postoperative chest X ray
Measured: 1 day (during surgery)
Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped
Delay between the end of administration of anesthetic drugs and return to spontaneous ventilation
Measured: 1 day (during surgery)
Evaluate the incidence of postoperative complications on day 1 in relation to the technique
Incidence of postoperative complications at day 1 after the surgery
Measured: 1 day
Evaluate the incidence of postoperative complications on day 7 in relation to the technique
Incidence of postoperative complications up to day 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start10 Mar 2022
- Primary completion11 Jul 2022
- Study completion18 Jul 2022
Why it stopped: Difficulty of recruiting and changing anesthesia methods
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, Dr, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369040
- Sponsor's protocol ID
- 2020_0016
- Acronym
- Ventinova ORL
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Ventilation Systems in Laryngeal Surgery: High-flow Nasal Oxygen Therapy and Laryngeal Micro-catheter With the Ventinova Technique
- ClinicalTrials.gov ID
- NCT04369040
- Acronym / sponsor ID
- Ventinova ORL / 2020_0016
- Conditions
- Laryngeal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of recruiting and changing anesthesia methods
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 30 Apr 2020 (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.
Single-center, randomized study, comparing two methods of oxygenation on 80 patients
Detailed description
This study is a single-center, randomized study, comparing two methods of oxygenation during micro-laryngeal surgery performed under general anesthesia and myorelaxation: high-flow nasal oxygen therapy (HFNO) or Flow Controlled Ventilation (FCV) using a laryngeal tri-tube. The study population will be composed of 80 patients, aged over 18 and under 80.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal oxygen therapy | Other | Device: High-flow nasal oxygen therapy using a specific nasal cannulaVentilation with High-flow nasal oxygen therapy |
| Flow Controlled Ventilation | Experimental | Device: Flow Controlled Ventilation using a laryngeal tri-tubeVentilation with laryngeal tri-tube with Flow Controlled Ventilation technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over the age of 18 and under the age of 80
- Patient to benefit from micro-laryngeal ENT surgery under general anesthesia and myorelaxation with an estimated duration which does not exceed 30 minutes
- Having signed a consent form
- Being affiliated with a Health Insurance plan.
Key exclusion criteria (9 listed)
- Pregnant or lactating patient
- Patient with a weight <40 kg
- Obese patient (BMI> 30)
- Patient with foreseeable intubation difficulty
- Patient maintained under general anesthesia postoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal oxygen therapy using a specific nasal cannulaPatient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery | Device | High-flow nasal oxygen therapy |
| Flow Controlled Ventilation using a laryngeal tri-tubePatient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery | Device | Flow Controlled Ventilation |
Primary outcome
Compare the percentage of patients having oxygen desaturation during the procedure or a PaCO2 > 65 mmHg at its end with both methods (high-flow nasal oxygen therapy and the use of FCV modality via a laryngeal tri-tube).
Time frame: 1 day (during surgery)
% of patients having an oxygen desaturation (SpO2<92%) during the procedure OR a PaCO2 > 65 mmHg at its end
8 secondary outcomes
Evaluate the duration of oxygen therapy before desaturation in the two groups
Time frame: 1 day (during surgery)
Evaluate the quality of the visualization of the laryngeal region in the two groups
Time frame: 1 day (during surgery)
Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques
Time frame: 1 day (during surgery)
Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)
Time frame: 1 day (during surgery)
Evaluate the incidence of atelectasis
Time frame: 1 day (during surgery)
Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped
Time frame: 1 day (during surgery)
Evaluate the incidence of postoperative complications on day 1 in relation to the technique
Time frame: 1 day
Evaluate the incidence of postoperative complications on day 7 in relation to the technique
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Difficulty of recruiting and changing anesthesia methods). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Morgan Le Guen, Dr principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal oxygen therapy using a specific nasal cannula in people with Laryngeal Disease, run by Hopital Foch 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 4 Apr 2025. 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?
The study was stopped early (reason given: Difficulty of recruiting and changing anesthesia methods). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the percentage of patients having oxygen desaturation during the procedure or a PaCO2 > 65 mmHg at its end with both methods (high-flow nasal oxygen therapy and the use of FCV modality via a laryngeal tri-tube). (time frame: 1 day (during surgery)). 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 4 Apr 2025.