Preoxygenation for Difficult Airway Management

NCT03604120 | Completed DMC

• 1 other identifier: RC17_0474
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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

Conditions

Intubation;Difficult

Keywords

Preoxygenation; High flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement of quality of preoxygenation

  4 minutes

• Reduction in side effects incidence related to intubation

  6 hours

• Morbi-mortality during surgery.

  6 hours

Study Arms (2)

Preoxygenation with high flow therapy by nasal cannula

EXPERIMENTAL

High flow oxygen therapy by nasal cannula.

Device: Preoxygenation with high flow therapy by nasal cannula

Preoxygenation by standard Facial mask

ACTIVE COMPARATOR

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

Interventions

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 with high flow therapy by nasal cannula

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.

Preoxygenation by standard Facial mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (2)

• Vourc'h M, Huard D, Le Penndu M, Deransy R, Surbled M, Malidin M, Mahe PJ, Guitton C, Roquilly A, Malard O, Feuillet F, Rozec B, Asehnoune K. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998. doi: 10.1016/j.eclinm.2023.101998. eCollection 2023 Jun.

  PMID: 37251624 DERIVED

• Vourc'h M, Huard D, Feuillet F, Baud G, Guichoux A, Surbled M, Tissot M, Chiffoleau A, Guitton C, Jaber S, Asehnoune K. Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study. BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909.

  PMID: 31028041 DERIVED

Study Officials

• Mickael VOURC'H, PH

  Nantes University Hospital

  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: June 22, 2018
• First Posted: July 27, 2018
• Study Start: September 19, 2018
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

FR (1)