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NCT Number: NCT07004699

Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHD Vendée, La Roche-sur-Yon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Laryngoscopy

Procedure

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 therapy

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of patients with intraoperative complications

    Time frame: During the surgical procedure

    Presence of bleeding from mouth and pharynx and rupture of teeth related to laryngoscopy

  2. Postoperative laryngeal pain

    Time frame: When leaving the Post Interventional Monitoring Room

    Laryngeal pain will be assessed using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)

  3. Comfort of the surgeon during the surgery

    Time frame: At the end of the surgical procedure

    Comfort will be assessed with a numerical rating scale ranging from 0 (very uncomfortable) to 10 (very comfortable)

  4. Duration of the surgical procedure

    Time frame: At the end of the surgical procedure

    Time will be measured from the suspension laryngoscopy to the end of the procedure (expressed in minutes)

  5. Duration of anaesthesia

    Time frame: At the end of the surgical procedure

    Time will be measured from the preoxygenation to awakening (expressed in minutes)

  6. Standardised cumulated dose of anaesthetic agents

    Time frame: At the end of the surgical procedure

    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.

  7. Per- and postoperative gas exchange

    Time frame: During the surgical procedure and at the end of the surgical procedure

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume BEAUMATIN

CONTACT

[email protected]

+33549443652

Rémi DRILLEAU

CONTACT

[email protected]

+33549446049

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

OPTIGO /Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus: Multicentre, Randomised, Non-inferiority Trial

Acronym: OPTIGO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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