Acute Respiratory Failure Requiring ReintubationHIGH-WEANNCT03121482
High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period
A study testing HFNC and NIV in people with Acute Respiratory Failure Requiring Reintubation, run by Poitiers University Hospital at 1 site in France.
Trial summary
Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure Requiring Reintubation
- What is being tested?
- HFNC and NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2017to 17 Apr 2018
- 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
- Duration of mechanical ventilation prior to extubation at least 24h
- Planned extubation decided by the physician in charge of the patient after success of a weaning trial
- Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
Who cannot join
- Patient admitted for traumatic brain injury
- Periphal neuromuscular disease as reason for intubation
- Usual lon-term treatment with NIV for chronic desease
- Usual lon-term treatment with CPAP for obstructive apneas syndrome
- Contraindication to NIV
- Unplanned extubation
Show all 10Show fewer
- Do-not-reintubated order at time of extubation
- Terminal extubation for end of life
- People under legal protection
- Opposition to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial
Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.
- Being tested
- HFNC, NIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%
NIVDevice
Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%
| Study group | Role | What they receive |
|---|---|---|
| HFNC alone | Active comparator | Control group Receives: Device: HFNC |
| HFNC and NIV | Experimental | Not described Receives: Device: HFNC; Device: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation at Day 7
The rate of reintubation will be assessed within the 7 days following planned extubation
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start20 Apr 2017
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure Requiring ReintubationStudies of the same condition, open and under way.
- 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
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud W THILLE, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121482
- Sponsor's protocol ID
- HIGH-WEAN Study
- Other IDs
- 2016-A01078-43
- Acronym
- HIGH-WEAN
- Status last verified
- Mar 2019
- First submitted
- 23 Mar 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Mekontso-Dessap A, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Frat JP, Ragot S; HIGH-WEAN Study Group and the REVA Research Network. Beneficial Effects of Noninvasive Ventilation after Extubation in Obese or Overweight Patients: A Post Hoc Analysis of a Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Feb 15;205(4):440-449. doi: 10.1164/rccm.202106-1452OC.
PubMed 34813391Thille AW, Monseau G, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA research network. Non-invasive ventilation versus high-flow nasal oxygen for postextubation respiratory failure in ICU: a post-hoc analysis of a randomized clinical trial. Crit Care. 2021 Jun 28;25(1):221. doi: 10.1186/s13054-021-03621-6.
PubMed 34183053Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group, for the REVA Research Network. Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Feb 9;11(1):30. doi: 10.1186/s13613-021-00823-7.
PubMed 33559765Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
PubMed 31577036Thille AW, Muller G, Gacouin A, Coudroy R, Demoule A, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Picard W, Bourenne J, Pradel G, Bailly P, Terzi N, Buscot M, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Ragot S, Frat JP; REVA research network. High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. BMJ Open. 2018 Sep 5;8(9):e023772. doi: 10.1136/bmjopen-2018-023772.
PubMed 30185583
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03121482
- Acronym / sponsor ID
- HIGH-WEAN / HIGH-WEAN Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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.
Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC alone | Active comparator | Device: HFNCControl group |
| HFNC and NIV | Experimental | Device: HFNC, Device: NIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duration of mechanical ventilation prior to extubation at least 24h
- Planned extubation decided by the physician in charge of the patient after success of a weaning trial
- Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
Key exclusion criteria (10 listed)
- Patient admitted for traumatic brain injury
- Periphal neuromuscular disease as reason for intubation
- Usual lon-term treatment with NIV for chronic desease
- Usual lon-term treatment with CPAP for obstructive apneas syndrome
- Contraindication to NIV
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 |
|---|---|---|
| HFNCGas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92% | Device | HFNC alone, HFNC and NIV |
| NIVPressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92% | Device | HFNC and NIV |
Primary outcome
Reintubation at Day 7
Time frame: up to 7 days
The rate of reintubation will be assessed within the 7 days following planned extubation
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 13 Mar 2019.
- Derived from this study: PubMed 34813391Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Mekontso-Dessap A, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Frat JP, Ragot S; HIGH-WEAN Study Group and the REVA Research Network. Beneficial Effects of Noninvasive Ventilation after Extubation in Obese or Overweight Patients: A Post Hoc Analysis of a Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Feb 15;205(4):440-449. doi: 10.1164/rccm.202106-1452OC.
- Derived from this study: PubMed 34183053Thille AW, Monseau G, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA research network. Non-invasive ventilation versus high-flow nasal oxygen for postextubation respiratory failure in ICU: a post-hoc analysis of a randomized clinical trial. Crit Care. 2021 Jun 28;25(1):221. doi: 10.1186/s13054-021-03621-6.
- Derived from this study: PubMed 33559765Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group, for the REVA Research Network. Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Feb 9;11(1):30. doi: 10.1186/s13613-021-00823-7.
- Derived from this study: PubMed 31577036Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
- Derived from this study: PubMed 30185583Thille AW, Muller G, Gacouin A, Coudroy R, Demoule A, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Picard W, Bourenne J, Pradel G, Bailly P, Terzi N, Buscot M, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Ragot S, Frat JP; REVA research network. High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. BMJ Open. 2018 Sep 5;8(9):e023772. doi: 10.1136/bmjopen-2018-023772.
- 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.
Arnaud W THILLE principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and NIV in people with Acute Respiratory Failure Requiring Reintubation, run by Poitiers University Hospital at 1 site 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 10 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reintubation at Day 7 (time frame: up to 7 days). 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 NCT03121482, which also lists 5 linked publications.
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 13 Mar 2019.