NCT03843580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

February 13, 2019

Last Update Submit

February 17, 2022

Conditions

Apnea, PostanestheticDesaturation of BloodApneaAnesthesiaLarynx DiseasePharynx; Anomaly

Keywords

Time of apneaOptiflowThriveApnea oxygenationSuspension laryngoscopyGeneral AnesthesiaOxygenation apnea

Outcome Measures

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%

    Two hours

Secondary Outcomes (2)

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

    2 hours

  • side effect

    2 hours

Other Outcomes (1)

  • time of apnea

    2 hours

Study Arms (2)

Standard Allocation

NO INTERVENTION

apnea without oxygenation like usual traitement

oxygenation optiflow

EXPERIMENTAL

optiflow oxygenation during apnea

Device: optiflow

Interventions

optiflowDEVICE

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

oxygenation optiflow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suspension laryngoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CaenUH

Caen, Normandy, 14000, France

Location

Centre François Baclesse

Caen, 14000, France

Location

MeSH Terms

Conditions

Butyrylcholinesterase deficiencyApneaLaryngeal DiseasesCongenital Abnormalities

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsOtorhinolaryngologic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 18, 2019

Study Start

April 23, 2019

Primary Completion

February 10, 2021

Study Completion

February 10, 2022

Last Updated

February 18, 2022

Record last verified: 2020-02

Locations

FR(2)