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NCT03843580 Clinical Trial

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

Anesthesia Clinical Trial

— optilaryngo  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03843580
Other study ID # 2019-A00112-55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 23, 2019
Est. completion date February 10, 2022

Study information
Verified date February 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date February 10, 2022
Est. primary completion date February 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - suspension laryngoscopy Exclusion Criteria: - THRIVE contraindication: - epistaxis - undrained pneumothorax - Recent gastroesophageal surgery (1months) - Skull Fractures

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CaenUH Caen Normandie
France Centre François Baclesse Caen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Caen Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Other time of apnea increase time of apnea with THRIVE 2 hours
Primary 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% Two hours
Secondary hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%) Decrease the number of Hypoxemia event define like SpO2<90% 2 hours
Secondary side effect decrease the number of side effects 2 hours
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