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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03604120
Other study ID # RC17_0474
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2018
Est. completion date March 8, 2021

Study information

Verified date May 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation


Description:

This study will be designed as followed: Patients will be randomized in 2 groups: - Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation. - Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date March 8, 2021
Est. primary completion date March 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients 18 years of aged and over - And anticipated difficult intubation - And requiring a rapid sequence induction for laryngoscopic intubation - Or requiring a fiberoptic intubation Exclusion Criteria: - BMI > 35 - Pulse oxymetry < 90% in ambient air - Haemodynamic instability - Pregnancy - Protected adult - Lack of consent - Patient already enrolled in another randomized study looking forward improving preoxygenation quality.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Preoxygenation with high flow therapy by nasal cannula
Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before fiber-optic or laryngoscopic intubation. The device will be maintained in place throughout the intubation procedure in order to achieve oxygenation.
Preoxygenation by standard Facial mask
For Fiber-optic intubation: patients will receive a 4 minutes FIBROXY facial mask preoxygenation with FiO2=100%. The FIBROXY facial mask will be maintained in place during the intubation procedure. For Laryngoscopic intubation: patients will receive a 4 minutes standard facial mask preoxygenation with FiO2=100%. The standard facial mask will be removed after crash induction to proceed to intubation.

Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure. To determine whether High-Flow nasal cannula used for preoxygenation and oxygenation during intubation, is more efficient than standard care during difficult intubation. This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry. 4 minutes
Secondary Improvement of quality of preoxygenation duration of proceedings 4 minutes
Secondary Reduction in side effects incidence related to intubation 6 hours
Secondary Morbi-mortality during surgery. Per and postoperative complication rate 6 hours
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