Preoxygenation for Difficult Airway Management

NCT ID: NCT03604120

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2021-03-08

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

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.

Conditions

Intubation;Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoxygenation with high flow therapy by nasal cannula

High flow oxygen therapy by nasal cannula.

Group Type: EXPERIMENTAL

Preoxygenation with high flow therapy by nasal cannula

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Preoxygenation by standard Facial mask

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickael VOURC'H, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37251624 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31028041 (View on PubMed)

Other Identifiers

RC17_0474

Identifier Type: -

Identifier Source: org_study_id