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CompletedNCT03843580optilaryngoUpdated Feb 18, 2022

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

An interventional study of optiflow in Apnea, Postanesthetic, Desaturation of Blood and Apnea, sponsored by University Hospital, Caen. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Apnea, Postanesthetic
  • Desaturation of Blood
  • Apnea
  • Anesthesia
  • Larynx Disease
  • Pharynx; Anomaly

Keywords

  • Time of apnea
  • Optiflow
  • Thrive
  • Apnea oxygenation
  • Suspension laryngoscopy
  • General Anesthesia
  • Oxygenation apnea
03

In context

Apnea

1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's enrollment of 80 is above the median of 51 across 966 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • suspension laryngoscopy

Exclusion criteria

Exclusion Criteria:

  • THRIVE contraindication:
  • epistaxis
  • undrained pneumothorax
  • Recent gastroesophageal surgery (1months)
  • Skull Fractures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    Standard Allocation

    apnea without oxygenation like usual traitement

  • Experimental
    oxygenation optiflow

    optiflow oxygenation during apnea

    Device: optiflow

Interventions

  • Deviceoptiflow

    we use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy

06

What researchers measure

Primary outcomes

  1. desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy

    the number of patient who presented at least one desaturation during suspension laryngoscopy. An oxygen desaturation define like SpO2\<96%

    Time frame: Two hours

Secondary outcomes

  1. hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)

    Decrease the number of Hypoxemia event define like SpO2\<90%

    Time frame: 2 hours

  2. side effect

    decrease the number of side effects

    Time frame: 2 hours

Other outcomes

  1. time of apnea

    increase time of apnea with THRIVE

    Time frame: 2 hours

07

Study locations

2 sites
  • CaenUH
    Caen, Normandie 14000, France
  • Centre François Baclesse
    Caen, 14000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03843580
Lead sponsor
University Hospital, Caen
Collaborators
Centre Francois Baclesse
Responsible party
Sponsor
First posted
Feb 18, 2019
Start date
Apr 23, 2019
Primary completion
Feb 10, 2021
Completion
Feb 10, 2022
Last update
Feb 18, 2022

Study contacts

Eleonore Mulac-Vauclair
principal investigator · Centre Francois Baclesse
Pierre-Emmanuel Marsan
principal investigator · University Hospital, Caen
Kamga Herve
principal investigator · University Hospital, Caen
Boutros Mariam
principal investigator · University Hospital, Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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