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

Primary Purpose

Need for Intubation, No Severe Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OPTIFLOW/ AIRVO
STANDARD Face Mask
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Need for Intubation, No Severe Hypoxemia focused on measuring non severely hypoxemic respiratory failure, preoxygenation, crash induction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brest hospital, CHU La cavale Blanche, medical intensive care unit
  • CHD LES OUDOUAIRIES Service de réanimation polyvalente
  • Ch Le Mans
  • Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit
  • Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
  • Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit
  • Nantes University hospital, Hôpital Laennec, pneumology intensive care unit
  • Tours university hospital, hôpital Bretonneau, medical intensive care unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow nasal cannula oxygen (HFNC)

STANDARD high flow Face Mask (HFFM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulse oximetry
number of desaturation events (under 80%)
Reduction in morbi-mortality during the Intensive care Unit stay
SOFA score

Full Information

First Posted
February 2, 2016
Last Updated
March 1, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02700321
Brief Title
Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients
Acronym
PROTRACH
Official Title
A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 28, 2016 (Actual)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Need for Intubation, No Severe Hypoxemia
Keywords
non severely hypoxemic respiratory failure, preoxygenation, crash induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow nasal cannula oxygen (HFNC)
Arm Type
Experimental
Arm Description
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.
Arm Title
STANDARD high flow Face Mask (HFFM)
Arm Type
Active Comparator
Arm Description
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
Device
Intervention Name(s)
OPTIFLOW/ AIRVO
Intervention Description
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
Procedure
Intervention Name(s)
STANDARD Face Mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
lowest pulse oxymetry (SpO2) during intubation
Description
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
Time Frame
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 Outcome Measure Information:
Title
Pulse oximetry
Time Frame
from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
Title
number of desaturation events (under 80%)
Time Frame
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)
Title
Reduction in morbi-mortality during the Intensive care Unit stay
Time Frame
from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
Title
SOFA score
Time Frame
Each day during the 5 first days after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier ZAMBON, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest hospital, CHU La cavale Blanche, medical intensive care unit
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHD LES OUDOUAIRIES Service de réanimation polyvalente
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Ch Le Mans
City
Le Mans
ZIP/Postal Code
72033
Country
France
Facility Name
Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Nantes University hospital, Hôpital Laennec, pneumology intensive care unit
City
St Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Tours university hospital, hôpital Bretonneau, medical intensive care unit
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30666367
Citation
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.
Results Reference
derived

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

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