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Completed

NCT Number: NCT03604120

Preoxygenation for Difficult Airway Management

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

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Key information

Conditions

Intubation;Difficult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoxygenation with high flow therapy by nasal cannula

Device

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

Device
  • 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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Improvement of quality of preoxygenation

    Time frame: 4 minutes

    duration of proceedings

  2. Reduction in side effects incidence related to intubation

    Time frame: 6 hours

  3. Morbi-mortality during surgery.

    Time frame: 6 hours

    Per and postoperative complication rate

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: PREOPTI-DAM

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2018
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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