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PREOPTI-DAM: Preoxygenation for Difficult Airway Management

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03604120
Collaborator
(none)
186
Enrollment
1
Location
2
Arms
29.6
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Preoxygenation with high flow therapy by nasal cannula
  • Device: Preoxygenation by standard Facial mask
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
186 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Sep 19, 2018
Actual Primary Completion Date :
Mar 8, 2021
Actual Study Completion Date :
Mar 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preoxygenation with high flow therapy by nasal cannula

High flow oxygen therapy by nasal cannula.

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.
Active Comparator: Preoxygenation by standard Facial mask

Patients randomized in "STANDARD FACIAL MASK" group will receive a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction or Fiber-optic intubation under spontaneous ventilation.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure. [4 minutes]

    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.

Secondary Outcome Measures

  1. Improvement of quality of preoxygenation [4 minutes]

    duration of proceedings

  2. Reduction in side effects incidence related to intubation [6 hours]

  3. Morbi-mortality during surgery. [6 hours]

    Per and postoperative complication rate

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nantes University Hospital Nantes France 44093

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Mickael VOURC'H, PH, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT03604120
Other Study ID Numbers:
  • RC17_0474
First Posted:
Jul 27, 2018
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Preoxygenation
High flow nasal cannula

Study Results

No Results Posted as of May 11, 2021