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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03843580
• Collaborator: Centre Francois Baclesse (Other)
• Enrollment: 80
• Locations: 2
• Arms: 2
• Actual Duration (Months): 33.6
• Patients Per Site: 40
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Apnea, Postanesthetic; Desaturation of Blood; Apnea; Anesthesia; Larynx Disease; Pharynx; Anomaly	Device: optiflow	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial
• Actual Study Start Date: Apr 23, 2019
• Actual Primary Completion Date: Feb 10, 2021
• Actual Study Completion Date: Feb 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

1. hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%) [2 hours]

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

2. side effect [2 hours]

   decrease the number of side effects

Other Outcome Measures

1. time of apnea [2 hours]

   increase time of apnea with THRIVE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• suspension laryngoscopy

Exclusion Criteria:

• THRIVE contraindication:

• epistaxis

• undrained pneumothorax

• Recent gastroesophageal surgery (1months)

• Skull Fractures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CaenUH	Caen	Normandie	France	14000
2	Centre François Baclesse	Caen		France	14000

Sponsors and Collaborators

• University Hospital, Caen
• Centre Francois Baclesse

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT03843580
• Other Study ID Numbers: 2019-A00112-55
• First Posted: Feb 18, 2019
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Caen: Time of apnea; Optiflow; Thrive; Apnea oxygenation; Suspension laryngoscopy; General Anesthesia; Oxygenation apnea
• Additional relevant MeSH terms: Apnea; Laryngeal Diseases

Study Results

No Results Posted as of Feb 18, 2022