Oxygen Inhalation Therapy EndoscopyOPTIGONCT07004699
Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus
A study testing Laryngoscopy and High-flow oxygen therapy in people with Oxygen Inhalation Therapy Endoscopy, run by Poitiers University Hospital at 3 sites in France.
Trial summary
Around 15,000 ENT cancers are diagnosed each year in France. The majority of these cancers will at one time or another require an Endoscopy of the Pharynx, Larynx and Esophagus (Endo-PLE or suspension laryngoscopy). Endoscopies of the Otorhinolaryngeal (ENT) sphere are common procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Inhalation Therapy Endoscopy
- What is being tested?
- Laryngoscopy and High-flow oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Jul 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient aged 18 or over.
- Scheduled for upper aerodigestive tract endoscopy (pharynx, larynx, oesophagus).
- ASA physical status I to IV.
- No requirment for preoperative supplemental oxygen.
- Informed consent signed.
Who cannot join
- Endoscopy combined with another procedure.
- Body mass index ≥ 35 kg/m².
- Severe chronic obstructive pulmonary disease (GOLD stage IV).
- Allergy to one of the anaesthetic agents (remifentanil, propofol, lidocaine).
- Baseline SpO2 ≤ 92% on arrival in the operating room
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Alexis DUCHALAIS, +33251446237, alexis.duchalais@ght85.fr
- Recruiting
CHU Limoges
Limoges, 87000
Simon KAROUTSOS, +33555055555, simon.karoutsos@chu-limoges.fr
- Recruiting
CHU Poitiers
Poitiers, 86000
Guillaume BEAUMATIN, +33549443652, guillaume.beaumatin@chu-poitiers.fr
Remi DRILLEAU
About this study
Official title: OPTIGO /Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus: Multicentre, Randomised, Non-inferiority Trial
Around 15,000 ENT cancers are diagnosed each year in France. The majority of these cancers will at one time or another require an Endoscopy of the Pharynx, Larynx and Esophagus (Endo-PLE or suspension laryngoscopy). Endoscopies of the Otorhinolaryngeal (ENT) sphere are common procedures. They consist of inserting a rigid laryngoscope through the mouth, allowing full exposure of the laryngeal sphere. For all patients, these endo-PLE are performed in the operating room and require general anesthesia. This surgical procedure is now performed by performing two laryngoscopies. The first is used to maintain good pulmonary oxygenation by introducing an oxygen cannula, the second constitutes the surgical procedure itself. The oxygen cannula is placed through the nasal cavity, directly up to the entrance of the vocal cords. This procedure is not without risk both for the patient (risk of dental breakage and bleeding during laryngoscopy) but also for the surgeon, because the cannula itself can obstruct his vision. It would be possible to do without one of them by setting up high-flow oxygen therapy (HFOT). This device has been widely deployed in continuous care and intensive care units, but is not yet the subject of much research in surgical units. The HFOT consists of oxygen cannulae delivering a mixture of gases at a high flow rate ranging from 20 to 70 liters per minute. The investigator want to evaluate through this study, the feasibility and effectiveness of setting up HFOT during procedures.
Read the detailed description
Endoscopy of the pharynx, larynx and oesophagus (endo-PLO) is a diagnostic procedure that enables the anatomical structures that enable speech, breathing and swallowing to be visualised. By keeping the patient on spontaneous ventilation (SV) during this procedure, the anatomical structures can be better observed. The examination lasts an average of 45 minutes, from the time the patient enters the operating theatre until he or she leaves.
Today, endo-PLO is performed using two laryngoscopies. Laryngoscopy involves inserting a curved piece of metal approximately 10 centimetres long into the patient's mouth, to expose the patient's vocal cords and insert a laryngeal device (oxygen probe, intubation probe) to enable the patient to be ventilated.
As part of an endo-PLO, an initial laryngoscopy is carried out by the State-qualified Anaesthetist Nurse or Anaesthetist Resuscitator . This first laryngoscopy is used to instil a 2% lidocaine solution (3 ml) between the vocal cords via a local anaesthetic spray device, which helps to provide intra- and post-operative analgesia. In a second stage, this first laryngoscopy will enable an oxygen cannula to be introduced via the patient's nasal cavities to the entrance to the vocal cords. Once this first laryngoscopy has been performed, the anaesthetic is gradually lifted so that the patient regains VS while remaining unconscious. A second laryngoscopy (suspension laryngoscopy) is then performed by the surgeon to proceed with the operation. Once the procedure is complete, the nasal cannula is removed and the patient awakened in the operating theatre.
In the case of ENT cancers, this tumour damage weakens the anatomical structures and encourages bleeding at the slightest contact.
As with any procedure, there is a significant risk of damage to these anatomical structures during laryngoscopy. As the tissues of the laryngeal walls are very fragile, there is a major risk of bleeding, which may cause difficulties in carrying out the surgical procedure.
High-flow oxygen therapy (HFOT) is a medical technology that has been in use for many years, particularly at Poitiers University Hospital. This device enables oxygen to be administered and delivered at flow rates ranging from 20 to 70 litres per minute (L/min), with the capacity to produce an inspired fraction of oxygen (FiO2) of between 21% and 100%. It consists of a gas mixer, connected to a heater and humidifier for comfortable, optimal delivery of the gas mixture. The heater keeps the inspired gases at an average temperature of 37°C, while the humidifier prevents the patient's airways from drying out. The gas mixture comes from two different connections, linked to an air and oxygen intake, to ensure that the FiO2 recorded is the same as that delivered to the patient.
- Conditions
- Oxygen Inhalation Therapy Endoscopy
- Being tested
- Laryngoscopy, High-flow oxygen therapy
- Keywords
- high-flow nasal oxygen, upper aerodigestive tract endoscopy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaryngoscopyProcedure or surgery
Introduction of the laryngoscope to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere.
High-flow oxygen therapyProcedure or surgery
Introduction of High-flow oxygen therapy to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere.
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscopy | Active comparator | Standard oxygenation using a nasopharyngeal oxygen catheter Receives: Procedure: Laryngoscopy |
| High-flow nasal oxygen therapy | Experimental | Oxygen delivered via heated and humidified high-flow nasal cannula Receives: Procedure: High-flow oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with intraoperative oxygen desaturation
Oxygen desaturation is defined as the onset of an episode of SpO2 ≤ 85% during the surgery
Measured: During the surgical procedure
Secondary outcomes (7)
Proportion of patients with intraoperative complications
Presence of bleeding from mouth and pharynx and rupture of teeth related to laryngoscopy
Measured: During the surgical procedure
Postoperative laryngeal pain
Laryngeal pain will be assessed using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: When leaving the Post Interventional Monitoring Room
Comfort of the surgeon during the surgery
Comfort will be assessed with a numerical rating scale ranging from 0 (very uncomfortable) to 10 (very comfortable)
Measured: At the end of the surgical procedure
Duration of the surgical procedure
Time will be measured from the suspension laryngoscopy to the end of the procedure (expressed in minutes)
Measured: At the end of the surgical procedure
Duration of anaesthesia
Time will be measured from the preoxygenation to awakening (expressed in minutes)
Measured: At the end of the surgical procedure
Standardised cumulated dose of anaesthetic agents
Cumulated doses of remifentanil and propofol will be summed up and standardised by the body weight of the patient. Standardised cumulated dose will be expressed in mg/kg.
Measured: At the end of the surgical procedure
Per- and postoperative gas exchange
PO2 (in mmHg), PCO2 (in mmHg), pH (no unit) and ScO2 (in %) will be measured at the beginning of the procedure and at awakening of the patient
Measured: During the surgical procedure and at the end of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start11 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen Inhalation Therapy EndoscopyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BEAUMATIN, Study director, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004699
- Sponsor's protocol ID
- OPTIGO
- Acronym
- OPTIGO
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alleyrat C, Drilleau R, Brasseur JM, Karayan J, Saenz-Molina C, Frasca D, Boisson M, Beaumatin G. High-flow nasal oxygen versus nasopharyngeal oxygen insufflation during upper aerodigestive tract endoscopy: protocol for a multicentre randomised controlled non-inferiority trial (OPTIGO). BMJ Open. 2026 Jun 1;16(6):e112540. doi: 10.1136/bmjopen-2025-112540.
PubMed 42225363
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIGO /Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus: Multicentre, Randomised, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07004699
- Acronym / sponsor ID
- OPTIGO / OPTIGO
- Conditions
- Oxygen Inhalation Therapy Endoscopy
- Keywords
- high-flow nasal oxygen, upper aerodigestive tract endoscopy, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Jun 2025 (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.
Around 15,000 ENT cancers are diagnosed each year in France. The majority of these cancers will at one time or another require an Endoscopy of the Pharynx, Larynx and Esophagus (Endo-PLE or suspension laryngoscopy). Endoscopies of the Otorhinolaryngeal (ENT) sphere are common procedures. They consist of inserting a rigid laryngoscope through the mouth, allowing full exposure of the laryngeal sphere. For all patients, these endo-PLE are performed in the operating room and require general anesthesia. This surgical procedure is now performed by performing two laryngoscopies. The first is used to maintain good pulmonary oxygenation by introducing an oxygen cannula, the second constitutes the surgical procedure itself. The oxygen cannula is placed through the nasal cavity, directly up to the entrance of the vocal cords. This procedure is not without risk both for the patient (risk of dental breakage and bleeding during laryngoscopy) but also for the surgeon, because the cannula itself can obstruct his vision. It would be possible to do without one of them by setting up high-flow oxygen therapy (HFOT). This device has been widely deployed in continuous care and intensive care units, but is not yet the subject of much research in surgical units. The HFOT consists of oxygen cannulae delivering a mixture of gases at a high flow rate ranging from 20 to 70 liters per minute. The investigator want to evaluate through this study, the feasibility and effectiveness of setting up HFOT during procedures.
Detailed description
Endoscopy of the pharynx, larynx and oesophagus (endo-PLO) is a diagnostic procedure that enables the anatomical structures that enable speech, breathing and swallowing to be visualised. By keeping the patient on spontaneous ventilation (SV) during this procedure, the anatomical structures can be better observed. The examination lasts an average of 45 minutes, from the time the patient enters the operating theatre until he or she leaves.
Today, endo-PLO is performed using two laryngoscopies. Laryngoscopy involves inserting a curved piece of metal approximately 10 centimetres long into the patient's mouth, to expose the patient's vocal cords and insert a laryngeal device (oxygen probe, intubation probe) to enable the patient to be ventilated.
As part of an endo-PLO, an initial laryngoscopy is carried out by the State-qualified Anaesthetist Nurse or Anaesthetist Resuscitator . This first laryngoscopy is used to instil a 2% lidocaine solution (3 ml) between the vocal cords via a local anaesthetic spray device, which helps to provide intra- and post-operative analgesia. In a second stage, this first laryngoscopy will enable an oxygen cannula to be introduced via the patient's nasal cavities to the entrance to the vocal cords. Once this first laryngoscopy has been performed, the anaesthetic is gradually lifted so that the patient regains VS while remaining unconscious. A second laryngoscopy (suspension laryngoscopy) is then performed by the surgeon to proceed with the operation. Once the procedure is complete, the nasal cannula is removed and the patient awakened in the operating theatre.
In the case of ENT cancers, this tumour damage weakens the anatomical structures and encourages bleeding at the slightest contact.
As with any procedure, there is a significant risk of damage to these anatomical structures during laryngoscopy. As the tissues of the laryngeal walls are very fragile, there is a major risk of bleeding, which may cause difficulties in carrying out the surgical procedure.
High-flow oxygen therapy (HFOT) is a medical technology that has been in use for many years, particularly at Poitiers University Hospital. This device enables oxygen to be administered and delivered at flow rates ranging from 20 to 70 litres per minute (L/min), with the capacity to produce an inspired fraction of oxygen (FiO2) of between 21% and 100%. It consists of a gas mixer, connected to a heater and humidifier for comfortable, optimal delivery of the gas mixture. The heater keeps the inspired gases at an average temperature of 37°C, while the humidifier prevents the patient's airways from drying out. The gas mixture comes from two different connections, linked to an air and oxygen intake, to ensure that the FiO2 recorded is the same as that delivered to the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngoscopy | Active comparator | Procedure: LaryngoscopyStandard oxygenation using a nasopharyngeal oxygen catheter |
| High-flow nasal oxygen therapy | Experimental | Procedure: High-flow oxygen therapyOxygen delivered via heated and humidified high-flow nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 or over.
- Scheduled for upper aerodigestive tract endoscopy (pharynx, larynx, oesophagus).
- ASA physical status I to IV.
- No requirment for preoperative supplemental oxygen.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Endoscopy combined with another procedure.
- Body mass index ≥ 35 kg/m².
- Severe chronic obstructive pulmonary disease (GOLD stage IV).
- Allergy to one of the anaesthetic agents (remifentanil, propofol, lidocaine).
- Baseline SpO2 ≤ 92% on arrival in the operating room
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 |
|---|---|---|
| LaryngoscopyIntroduction of the laryngoscope to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere. | Procedure or surgery | Laryngoscopy |
| High-flow oxygen therapyIntroduction of High-flow oxygen therapy to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere. | Procedure or surgery | High-flow nasal oxygen therapy |
Primary outcome
Proportion of patients with intraoperative oxygen desaturation
Time frame: During the surgical procedure
Oxygen desaturation is defined as the onset of an episode of SpO2 ≤ 85% during the surgery
7 secondary outcomes
Proportion of patients with intraoperative complications
Time frame: During the surgical procedure
Postoperative laryngeal pain
Time frame: When leaving the Post Interventional Monitoring Room
Comfort of the surgeon during the surgery
Time frame: At the end of the surgical procedure
Duration of the surgical procedure
Time frame: At the end of the surgical procedure
Duration of anaesthesia
Time frame: At the end of the surgical procedure
Standardised cumulated dose of anaesthetic agents
Time frame: At the end of the surgical procedure
Per- and postoperative gas exchange
Time frame: During the surgical procedure and at the end of the surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 42225363Alleyrat C, Drilleau R, Brasseur JM, Karayan J, Saenz-Molina C, Frasca D, Boisson M, Beaumatin G. High-flow nasal oxygen versus nasopharyngeal oxygen insufflation during upper aerodigestive tract endoscopy: protocol for a multicentre randomised controlled non-inferiority trial (OPTIGO). BMJ Open. 2026 Jun 1;16(6):e112540. doi: 10.1136/bmjopen-2025-112540.
- 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.
Guillaume BEAUMATIN study director
Poitiers University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscopy and High-flow oxygen therapy in people with Oxygen Inhalation Therapy Endoscopy, run by Poitiers University Hospital at 3 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume BEAUMATIN (+33549443652, guillaume.beaumatin@chu-poitiers.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 intraoperative oxygen desaturation (time frame: During the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004699, which also lists 1 linked publication.
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 31 Aug 2026.