Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo) (optilaryngo)

February 17, 2022 updated by: University Hospital, Caen

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial

Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.

So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Centre François Baclesse
    • Normandie
      • Caen, Normandie, France, 14000
        • CaenUH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • suspension laryngoscopy

Exclusion Criteria:

  • THRIVE contraindication:
  • epistaxis
  • undrained pneumothorax
  • Recent gastroesophageal surgery (1months)
  • Skull Fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard Allocation
apnea without oxygenation like usual traitement
EXPERIMENTAL: oxygenation optiflow
optiflow oxygenation during apnea
Device: optiflow
we use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy
Time Frame: Two hours
the number of patient who presented at least one desaturation during suspension laryngoscopy. An oxygen desaturation define like SpO2<96%
Two hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)
Time Frame: 2 hours
Decrease the number of Hypoxemia event define like SpO2<90%
2 hours
side effect
Time Frame: 2 hours
decrease the number of side effects
2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of apnea
Time Frame: 2 hours
increase time of apnea with THRIVE
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Centre Francois Baclesse

Investigators

  • Principal Investigator: Eleonore Mulac-Vauclair, Centre François Baclesse
  • Principal Investigator: Pierre-Emmanuel Marsan, University Hospital, Caen
  • Principal Investigator: Kamga Herve, University Hospital, Caen
  • Principal Investigator: Boutros Mariam, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2019

Primary Completion (ACTUAL)

February 10, 2021

Study Completion (ACTUAL)

February 10, 2022

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00112-55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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