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

NCT ID: NCT02700321

Last Updated: 2019-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-28

Study Completion Date

2017-10-05

Brief Summary

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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

Detailed Description

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This study will be designed as followed : patients will be randomized in 2 groups : High Flow nasal cannula "HFNC" or standard High Flow face mask "HFFM".

Patients randomized in "HFNC" group will receive a four minutes preoxygenation period with Nasal High Flow Therapy (60 L/mn , fraction of inspired oxygen (FI02) = 100%) before orotracheal intubation under laryngoscopy after crash induction. After induction and during laryngoscopy, HFNC will be maintained in an attempt to achieve apneic oxygenation.

Patients randomized in "HFFM" group will received a four minutes preoxygenation period with standard face mask (15 L/mn) before orotracheal intubation under laryngoscopy after crash induction. After induction, HFFM will be removed, enabling laryngoscopic vision

Conditions

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Need for Intubation, No Severe Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Flow nasal cannula oxygen (HFNC)

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.

Group Type EXPERIMENTAL

OPTIFLOW/ AIRVO

Intervention Type 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.

STANDARD high flow Face Mask (HFFM)

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.

Group Type ACTIVE_COMPARATOR

STANDARD Face Mask

Intervention Type 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.

Interventions

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OPTIFLOW/ AIRVO

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.

Intervention Type DEVICE

STANDARD Face Mask

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults older than 18 years regardless of the gender
* Requiring orotracheal intubation in intensive care unit
* "No severely hypoxemic respiratory failure" defined as Oxygen Pression (Pa02)/FI02 \> 200 mmHg measured in the 4 hours before inclusion

Exclusion Criteria

* 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
* Patients with a documented Cormack IV exposition before inclusion
* Protected adult
* Pregnancy or breastfeeding
* Lack of consent
* Patient already enrolled in another study that could interfere with the primary objective of this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier ZAMBON, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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

Brest, , France

Site Status

CHD LES OUDOUAIRIES Service de réanimation polyvalente

La Roche-sur-Yon, , France

Site Status

Ch Le Mans

Le Mans, , France

Site Status

Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit

Nantes, , France

Site Status

Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

Nantes, , France

Site Status

Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit

Rennes, , France

Site Status

Nantes University hospital, Hôpital Laennec, pneumology intensive care unit

Saint-Herblain, , France

Site Status

Tours university hospital, hôpital Bretonneau, medical intensive care unit

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30666367 (View on PubMed)

Other Identifiers

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RC15_0047

Identifier Type: -

Identifier Source: org_study_id

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