Back to resultsTransnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo) (optilaryngo)
Primary Purpose
Apnea, Postanesthetic, Desaturation of Blood, Apnea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
optiflow
Sponsored by
About this trial
This is an interventional treatment trial for Apnea, Postanesthetic focused on measuring Time of apnea, Optiflow, Thrive, Apnea oxygenation, Suspension laryngoscopy, General Anesthesia, Oxygenation apnea
Eligibility Criteria
Inclusion Criteria:
- suspension laryngoscopy
Exclusion Criteria:
- THRIVE contraindication:
- epistaxis
- undrained pneumothorax
- Recent gastroesophageal surgery (1months)
- Skull Fractures
Sites / Locations
- CaenUH
- Centre François Baclesse
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Allocation
oxygenation optiflow
Arm Description
apnea without oxygenation like usual traitement
optiflow oxygenation during apnea
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)
Decrease the number of Hypoxemia event define like SpO2<90%
side effect
decrease the number of side effects
Full Information
NCT ID
NCT03843580
First Posted
February 13, 2019
Last Updated
February 17, 2022
Sponsor
University Hospital, Caen
Collaborators
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT03843580
Brief Title
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo)
Acronym
optilaryngo
Official Title
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Centre Francois Baclesse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Allocation
Arm Type
No Intervention
Arm Description
apnea without oxygenation like usual traitement
Arm Title
oxygenation optiflow
Arm Type
Experimental
Arm Description
optiflow oxygenation during apnea
Intervention Type
Device
Intervention Name(s)
optiflow
Intervention Description
we use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy
Primary Outcome Measure Information:
Title
desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy
Description
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 Outcome Measure Information:
Title
hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)
Description
Decrease the number of Hypoxemia event define like SpO2<90%
Time Frame
2 hours
Title
side effect
Description
decrease the number of side effects
Time Frame
2 hours
Other Pre-specified Outcome Measures:
Title
time of apnea
Description
increase time of apnea with THRIVE
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suspension laryngoscopy
Exclusion Criteria:
THRIVE contraindication:
epistaxis
undrained pneumothorax
Recent gastroesophageal surgery (1months)
Skull Fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleonore Mulac-Vauclair
Organizational Affiliation
Centre Francois Baclesse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel Marsan
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamga Herve
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boutros Mariam
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CaenUH
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo)
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