Need for Intubation, No Severe HypoxemiaPROTRACHNCT02700321
Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients
A study testing OPTIFLOW/ AIRVO and STANDARD Face Mask in people with Need for Intubation, No Severe Hypoxemia, run by Nantes University Hospital at 8 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Need for Intubation, No Severe Hypoxemia
- What is being tested?
- OPTIFLOW/ AIRVO and STANDARD Face Mask
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 8 sitesFrance
- Study dates
- 28 Apr 2016to 5 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Brest hospital, CHU La cavale Blanche, medical intensive care unit
Brest, 29609
CHD LES OUDOUAIRIES Service de réanimation polyvalente
La Roche-sur-Yon, 85925
Ch Le Mans
Le Mans, 72033
Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit
Nantes, 44093
Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
Nantes, 44093
Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit
Rennes, 35033
Nantes University hospital, Hôpital Laennec, pneumology intensive care unit
Saint-Herblain, 44800
Tours university hospital, hôpital Bretonneau, medical intensive care unit
Tours, 37044
About this study
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
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
Read the 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
- Conditions
- Need for Intubation, No Severe Hypoxemia
- Being tested
- OPTIFLOW/ AIRVO, STANDARD Face Mask
- Keywords
- non severely hypoxemic respiratory failure, preoxygenation, crash induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIFLOW/ AIRVODevice
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 Face MaskProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: STANDARD Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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%)
Measured: 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
Measured: from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
SOFA score
Measured: Each day during the 5 first days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start28 Apr 2016
- Primary completion27 Jun 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Need for Intubation, No Severe HypoxemiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier ZAMBON, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700321
- Sponsor's protocol ID
- RC15_0047
- Acronym
- PROTRACH
- Status last verified
- Mar 2019
- First submitted
- 2 Feb 2016
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30666367
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02700321
- Acronym / sponsor ID
- PROTRACH / RC15_0047
- Conditions
- Need for Intubation, No Severe Hypoxemia
- Keywords
- non severely hypoxemic respiratory failure, preoxygenation, crash induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow nasal cannula oxygen (HFNC) | Experimental | Device: OPTIFLOW/ AIRVOPatients 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) | Active comparator | Procedure: STANDARD Face MaskPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIFLOW/ AIRVOPatients 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 | High Flow nasal cannula oxygen (HFNC) |
| STANDARD Face MaskPatients 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 or surgery | STANDARD high flow Face Mask (HFFM) |
Primary outcome
lowest pulse oxymetry (SpO2) during intubation
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
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
4 secondary outcomes
Pulse oximetry
Time frame: 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%)
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)
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)
SOFA score
Time frame: Each day during the 5 first days after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 30666367Guitton 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier ZAMBON, MD principal investigator
Nantes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIFLOW/ AIRVO and STANDARD Face Mask in people with Need for Intubation, No Severe Hypoxemia, run by Nantes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lowest pulse oxymetry (SpO2) during intubation (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.