Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

NCT02700321 | Completed

• 1 other identifier: RC15_0047
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 8

Brief Summary

The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

Conditions

Need for Intubation, No Severe Hypoxemia

Keywords

non severely hypoxemic respiratory failure; preoxygenation; crash induction

Outcome Measures

Primary Outcomes (1)

• lowest pulse oxymetry (SpO2) during intubation

  This outcome will be assessed from the beginning of the endotracheal intubation procedure (immediately after induction) to the end of orotracheal intubation (airway catheterization) by monitoring the pulse oxymetry

  From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes

Secondary Outcomes (4)

• Pulse oximetry

  from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes

• number of desaturation events (under 80%)

  From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)

• Reduction in morbi-mortality during the Intensive care Unit stay

  from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)

• SOFA score

  Each day during the 5 first days after randomisation

Study Arms (2)

High Flow nasal cannula oxygen (HFNC)

EXPERIMENTAL

Patients randomized in "HFNC" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/Airvo® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.

Device: OPTIFLOW/ AIRVO

STANDARD high flow Face Mask (HFFM)

ACTIVE COMPARATOR

Patients randomized in "Standard face mask" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction.

Procedure: STANDARD Face Mask

Interventions

OPTIFLOW/ AIRVO DEVICE

Patients randomized in "HFNC" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/AIRVO® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.

High Flow nasal cannula oxygen (HFNC)

STANDARD Face Mask PROCEDURE

Patients randomized in "STANDARD Face Mask" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction.

STANDARD high flow Face Mask (HFFM)

Eligibility Criteria

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

You may qualify if:

• Adults older than 18 years regardless of the gender
• Requiring orotracheal intubation in intensive care unit

You may not qualify if:

• Not the first Intubation during this stay in intensive care unit
• Contraindication to oro-tracheal intubation
• Intubation without anaesthesic rapid sequence induction
• Intubation during cardiac arrest
• Real emergency (as asphyxia) with immediate intubation needed (without time enough for randomization)
• Nasopharyngeal obstacle with contraindication to use Optiflow device
• Protected adult
• Pregnancy or breastfeeding
• Lack of consent
• Patient already enrolled in another study that could interfere with the primary objective of this study

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (8)

Brest hospital, CHU La cavale Blanche, medical intensive care unit

Brest, 29609, France

Location

CHD LES OUDOUAIRIES Service de réanimation polyvalente

La Roche-sur-Yon, 85925, France

Location

Ch Le Mans

Le Mans, 72033, France

Location

Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit

Nantes, 44093, France

Location

Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

Nantes, 44093, France

Location

Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit

Rennes, 35033, France

Location

Nantes University hospital, Hôpital Laennec, pneumology intensive care unit

Saint-Herblain, 44800, France

Location

Tours university hospital, hôpital Bretonneau, medical intensive care unit

Tours, 37044, France

Location

Related Publications (1)

• Guitton C, Ehrmann S, Volteau C, Colin G, Maamar A, Jean-Michel V, Mahe PJ, Landais M, Brule N, Bretonniere C, Zambon O, Vourc'h M. Nasal high-flow preoxygenation for endotracheal intubation in the critically ill patient: a randomized clinical trial. Intensive Care Med. 2019 Apr;45(4):447-458. doi: 10.1007/s00134-019-05529-w. Epub 2019 Jan 21.

  PMID: 30666367 DERIVED

Study Officials

• Olivier ZAMBON, MD

  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: February 2, 2016
• First Posted: March 7, 2016
• Study Start: April 28, 2016
• Primary Completion: June 27, 2017
• Study Completion: October 5, 2017
• Last Updated: March 4, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)