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Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery (FCVT-ENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369040
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
Single-center, randomized study, comparing two methods of oxygenation on 80 patients

Condition or disease Intervention/treatment Phase
Laryngeal Disease Device: High-flow nasal oxygen therapy using a specific nasal cannula Device: Flow Controlled Ventilation using a laryngeal tri-tube Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery: High-flow Nasal Oxygen Therapy and Flow Controlled Ventilation
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
High-flow nasal oxygen therapy
Ventilation with High-flow nasal oxygen therapy
Device: High-flow nasal oxygen therapy using a specific nasal cannula
Patient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery

Experimental: Flow Controlled Ventilation
Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique
Device: Flow Controlled Ventilation using a laryngeal tri-tube
Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluate the duration of oxygen therapy before desaturation in the two groups [ Time Frame: 1 day (during surgery) ]
    Delay before oxygen desaturation (SpO2<92%) during the procedure

  2. Evaluate the quality of the visualization of the laryngeal region in the two groups [ Time Frame: 1 day (during surgery) ]
    Percentage of glottic opening (POGO) score at laryngoscopy

  3. Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques [ Time Frame: 1 day (during surgery) ]
    PaCO2 (partial pressure of carbon dioxide) at the end of the procedure

  4. Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen) [ Time Frame: 1 day (during surgery) ]
    Minimal inspired fraction of oxygen during the procedure

  5. Evaluate the incidence of atelectasis [ Time Frame: 1 day (during surgery) ]
    Incidence of atelectasis on a postoperative chest X ray

  6. Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped [ Time Frame: 1 day (during surgery) ]
    Delay between the end of administration of anesthetic drugs and return to spontaneous ventilation

  7. Evaluate the incidence of postoperative complications on day 1 in relation to the technique [ Time Frame: 1 day ]
    Incidence of postoperative complications at day 1 after the surgery

  8. Evaluate the incidence of postoperative complications on day 7 in relation to the technique [ Time Frame: 7 days ]
    Incidence of postoperative complications up to day 7



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369040


Contacts
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Contact: Elisabeth Hulier-Ammar, Dr 0033146251175 e.hulier-ammar@hopital-foch.com

Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Morgan Le Guen, Dr Hopital Foch
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT04369040    
Other Study ID Numbers: 2020_0016
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases