- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03843580
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
-
-
-
Caen, France, 14000
- Centre Francois 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
|
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
Collaborators
Investigators
- Principal Investigator: Eleonore Mulac-Vauclair, Centre Francois 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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