Mechanical VentilationObiWEANNCT03689309
High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial.
A study testing High Flow Oxygen SBT in people with Mechanical Ventilation and Mechanical Ventilator Weaning, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care. Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Mechanical Ventilator Weaning, Endotracheal Extubation
- What is being tested?
- High Flow Oxygen SBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 15 Jul 2020
- 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
- Age > 18 yrs.
- Admission in ICU
- Mechanically ventilated > 24 hours
- Mechanically ventilated using support ventilation mode
- Patient with one of these criterion:
- Cardiac disease (left ventricular dysfunction LVEF <46%, antecedent of ischemic heart disease, antecedent of acute pulmonary edema)
- Respiratory disease (COPD, Emphysema, bronchectiasis, asthma, obesity-hypoventilation syndrome, restrictive pulmonary disease)
- Informed and signed consent from the patient or next of kin.
Who cannot join
- Head trauma as a cause for ICU admission
- Neuromuscular disease prior ICU admission
- Tracheotomized patient
- Pregnancy
- Decision not to forgo life sustaining therapy
- Patient not affiliated with a social security organism
- Adult private from his liberty with judicial decision
- Patient that have already been included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial. A Pilot Randomized Controlled Trial
In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care.
Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality.
Read more
The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation.
In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions.
In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need.
In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV.
In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy.
The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.
Read the detailed description
The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:
- Classic SBT (C-SBT)
- High Flow Oxygen SBT (HFO-SBT)
This prospective randomized study had 2 conjoint primary outcome:
- The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
- Compare the reintubation rate at D7 from the extubation
- Being tested
- High Flow Oxygen SBT
- Keywords
- Spontaneous breathing Trial, High Flow Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Oxygen SBTProcedure or surgery
The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy.
| Study group | Role | What they receive |
|---|---|---|
| 1. Classic SBT (C-SBT) | No intervention | The patient is disconnected from the ventilator and remains 30 minutes without support but oxygen delivered through a heat humidifier filter that is usually connected on tracheotomy. |
| 2. High Flow Oxygen SBT (HFO-SBT) | Experimental | The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy. Receives: Procedure: High Flow Oxygen SBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actuarial rate of extubation
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
- The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
- Compare the reintubation rate at D7 from the extubation
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
- The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
- Compare the reintubation rate at D7 from the extubation
Measured: Day 7
Reintubation Rate
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
- The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
- Compare the reintubation rate at D7 from the extubation
Measured: Day 7
Secondary outcomes (3)
Success rate of the first SBT
Success rate of the first SBT will be compared between the two groups.
Measured: Day 0
Ventilator free-days
Ventilator free-days at day 28 from the admission in ICU
Measured: Day 28
Rate of Ventilator Associated Pneumonia
Rate of Ventilator Associated Pneumonia at day 7 from the extubation
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start16 Oct 2018
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh NAY, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689309
- Sponsor's protocol ID
- CHRO-2018-06
- Acronym
- ObiWEAN
- Status last verified
- Jul 2020
- First submitted
- 27 Sep 2018
- Last updated
- 27 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
PubMed 23641924Ladeira MT, Vital FM, Andriolo RB, Andriolo BN, Atallah AN, Peccin MS. Pressure support versus T-tube for weaning from mechanical ventilation in adults. Cochrane Database Syst Rev. 2014 May 27;2014(5):CD006056. doi: 10.1002/14651858.CD006056.pub2.
PubMed 24865303Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
PubMed 7921460
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial. A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03689309
- Acronym / sponsor ID
- ObiWEAN / CHRO-2018-06
- Keywords
- Spontaneous breathing Trial, High Flow Oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 28 Sep 2018 (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.
In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care.
Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality.
The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation.
In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions.
In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need.
In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV.
In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy.
The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.
Detailed description
The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:
- Classic SBT (C-SBT)
- High Flow Oxygen SBT (HFO-SBT)
This prospective randomized study had 2 conjoint primary outcome:
- The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
- Compare the reintubation rate at D7 from the extubation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Classic SBT (C-SBT) | No intervention | –The patient is disconnected from the ventilator and remains 30 minutes without support but oxygen delivered through a heat humidifier filter that is usually connected on tracheotomy. |
| 2. High Flow Oxygen SBT (HFO-SBT) | Experimental | Procedure: High Flow Oxygen SBTThe patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 yrs.
- Admission in ICU
- Mechanically ventilated > 24 hours
- Mechanically ventilated using support ventilation mode
- Patient with one of these criterion:
Key exclusion criteria (8 listed)
- Head trauma as a cause for ICU admission
- Neuromuscular disease prior ICU admission
- Tracheotomized patient
- Pregnancy
- Decision not to forgo life sustaining therapy
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 |
|---|---|---|
| High Flow Oxygen SBTThe patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy. | Procedure or surgery | 2. High Flow Oxygen SBT (HFO-SBT) |
Primary outcome
Actuarial rate of extubation
Time frame: Day 7
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation
Reintubation Rate
Time frame: Day 7
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation
3 secondary outcomes
Success rate of the first SBT
Time frame: Day 0
Ventilator free-days
Time frame: Day 28
Rate of Ventilator Associated Pneumonia
Time frame: Day 7
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 27 Jul 2020.
- Background: PubMed 23641924Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
- Background: PubMed 24865303Ladeira MT, Vital FM, Andriolo RB, Andriolo BN, Atallah AN, Peccin MS. Pressure support versus T-tube for weaning from mechanical ventilation in adults. Cochrane Database Syst Rev. 2014 May 27;2014(5):CD006056. doi: 10.1002/14651858.CD006056.pub2.
- Background: PubMed 7921460Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
- Individual participant dataSharing planned: No
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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.
Mai-Anh NAY, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Oxygen SBT in people with Mechanical Ventilation and Mechanical Ventilator Weaning, run by Centre Hospitalier Régional d'Orléans 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 8 inclusion and 8 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 27 Jul 2020. 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?
Actuarial rate of extubation (time frame: Day 7). The study lists 2 primary outcomes in all. 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 NCT03689309, which also lists 3 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 27 Jul 2020.