Acute Respiratory InsufficiencyWEANINGNCT02939963
Ventilation Strategies During Spontaneous Breathing Trial
A study testing ATC then pressure support 7 cm H2O PEP 4 cm H2O and Pressure support 7 cm H2O PEP 4 cm H2O then ATC in people with Acute Respiratory Insufficiency, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Insufficiency
- What is being tested?
- ATC then pressure support 7 cm H2O PEP 4 cm H2O and Pressure support 7 cm H2O PEP 4 cm H2O then ATC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2017to 5 Oct 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
- age 18 years or more
- intubated and mechanically ventilated for at least 24 consecutive hours
- staying in the medical ICU at the Croix Rousse Hospital, Lyon, France
- pressure support ventilation 10-15 cm H2O, total respiratory rate 25-35 breaths/min, expired tidal volume 6-8 ml/kg predicted body weight
- meeting criteria for spontaneous breathing trial (able to answer simple questions, no ongoing intravenous sedation, norepinephrine ≤ 1 mg/H, dobutamine ≤ 20 mg/h, fraction of inspired oxygen (FIO2 ≤ 50%), PEP ≤ 5 cm H2O, respiratory rate ≤ 35 breaths/min, saturation in oxygen (SpO2) ≥88%)
- under Dräger Evita XL ou V500 ICU ventilator
- agreement to participate from the patient or next of kin
Who cannot join
- Chronic respiratory failure under long term home oxygen therapy and/or non invasive ventilation before ICU admission
- Tracheotomy
- nasogastric tube contra-indicated
- thoracic tube in place
- no agreement to participate
- under justice protection
Show all 10Show fewer
- deprived of freedom
- pregnant or breastfeeding
- not affiliated to social insurance
- involved into another study that may interfere with present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients
Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.
Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.
- Conditions
- Acute Respiratory Insufficiency
- Being tested
- ATC then pressure support 7 cm H2O PEP 4 cm H2O, Pressure support 7 cm H2O PEP 4 cm H2O then ATC
- Keywords
- weaning, mechanical ventilation, work of breathing, automatic tube compensation, pressure support ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATC then pressure support 7 cm H2O PEP 4 cm H2OProcedure or surgery
spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O during 30 minutes then 30 minutes of basal pressure support then 30 minutes with pressure support 7 cm H2O PEP 4 cm H2O
Pressure support 7 cm H2O PEP 4 cm H2O then ATCProcedure or surgery
30 minutes with pressure support 7 cm H2O PEP 4 cm H2O then 30 minutes of basal pressure support then 30 minutes with spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| ATC then pressure support 7 cm H2O PEP 4 cm H2O | Experimental | spontaneous breathing through endotracheal tube with no ventilator support except for ATC Receives: Procedure: ATC then pressure support 7 cm H2O PEP 4 cm H2O |
| pressure support 7 cm H2O PEP 4 cm H2O then ATC | Experimental | ventilator is set to pressure support ventilation mode at set pressure 7 cm H2O above PEEP level of 4 cm H2O Receives: Procedure: Pressure support 7 cm H2O PEP 4 cm H2O then ATC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the power of work of breathing
the work of breathing is measured from the area subtended by the esophageal pressure - lung volume relationship. The power of work of breathing is obtained by multiplying work of breathing by the respiratory frequency and expressed in Joules/min
Measured: 30 minutes after onset the ventilator strategy
Secondary outcomes (6)
Respiratory rate
the respiratory rate is measured from the airflow tracing
Measured: 30 minutes
tidal volume
integration of airflow over time during expiration
Measured: 30 minutes
intrinsic PEP
deflection in esophageal pressure up to the first zero flow
Measured: 30 minutes
occlusion pressure at 100 ms
measured from the airway pressure at the first 100 ms after airway occlusion
Measured: 30 minutes
work of breathing per liter
work of breathing normalized for 1 liter tidal volume
Measured: 30 minutes
Distribution of pulmonary ventilation
distribution of pulmonary ventilation will be measured by the Pulmovista system
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start23 Aug 2017
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
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 Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Guerin, Pr, Principal investigator, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939963
- Sponsor's protocol ID
- 69HCL16_0411
- Other IDs
- 2016-A01172-49
- Acronym
- WEANING
- Status last verified
- Sep 2025
- First submitted
- 19 Oct 2016
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guerin C, Terzi N, Mezidi M, Baboi L, Chebib N, Yonis H, Argaud L, Heunks L, Louis B. Low-pressure support vs automatic tube compensation during spontaneous breathing trial for weaning. Ann Intensive Care. 2019 Dec 13;9(1):137. doi: 10.1186/s13613-019-0611-y.
PubMed 31836913
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients
- ClinicalTrials.gov ID
- NCT02939963
- Acronym / sponsor ID
- WEANING / 69HCL16_0411
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- weaning, mechanical ventilation, work of breathing, automatic tube compensation, pressure support ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 20 Oct 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.
Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.
Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATC then pressure support 7 cm H2O PEP 4 cm H2O | Experimental | Procedure: ATC then pressure support 7 cm H2O PEP 4 cm H2Ospontaneous breathing through endotracheal tube with no ventilator support except for ATC |
| pressure support 7 cm H2O PEP 4 cm H2O then ATC | Experimental | Procedure: Pressure support 7 cm H2O PEP 4 cm H2O then ATCventilator is set to pressure support ventilation mode at set pressure 7 cm H2O above PEEP level of 4 cm H2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 years or more
- intubated and mechanically ventilated for at least 24 consecutive hours
- staying in the medical ICU at the Croix Rousse Hospital, Lyon, France
- pressure support ventilation 10-15 cm H2O, total respiratory rate 25-35 breaths/min, expired tidal volume 6-8 ml/kg predicted body weight
- meeting criteria for spontaneous breathing trial (able to answer simple questions, no ongoing intravenous sedation, norepinephrine ≤ 1 mg/H, dobutamine ≤ 20 mg/h, fraction of inspired oxygen (FIO2 ≤ 50%), PEP ≤ 5 cm H2O, respiratory rate ≤ 35 breaths/min, saturation in oxygen (SpO2) ≥88%)
Key exclusion criteria (10 listed)
- Chronic respiratory failure under long term home oxygen therapy and/or non invasive ventilation before ICU admission
- Tracheotomy
- nasogastric tube contra-indicated
- thoracic tube in place
- no agreement to participate
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 |
|---|---|---|
| ATC then pressure support 7 cm H2O PEP 4 cm H2Ospontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O during 30 minutes then 30 minutes of basal pressure support then 30 minutes with pressure support 7 cm H2O PEP 4 cm H2O | Procedure or surgery | ATC then pressure support 7 cm H2O PEP 4 cm H2O |
| Pressure support 7 cm H2O PEP 4 cm H2O then ATC30 minutes with pressure support 7 cm H2O PEP 4 cm H2O then 30 minutes of basal pressure support then 30 minutes with spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O | Procedure or surgery | pressure support 7 cm H2O PEP 4 cm H2O then ATC |
Primary outcome
the power of work of breathing
Time frame: 30 minutes after onset the ventilator strategy
the work of breathing is measured from the area subtended by the esophageal pressure - lung volume relationship. The power of work of breathing is obtained by multiplying work of breathing by the respiratory frequency and expressed in Joules/min
6 secondary outcomes
Respiratory rate
Time frame: 30 minutes
tidal volume
Time frame: 30 minutes
intrinsic PEP
Time frame: 30 minutes
occlusion pressure at 100 ms
Time frame: 30 minutes
work of breathing per liter
Time frame: 30 minutes
Distribution of pulmonary ventilation
Time frame: 30 minutes
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 18 Sep 2025.
- Results publication: PubMed 31836913Guerin C, Terzi N, Mezidi M, Baboi L, Chebib N, Yonis H, Argaud L, Heunks L, Louis B. Low-pressure support vs automatic tube compensation during spontaneous breathing trial for weaning. Ann Intensive Care. 2019 Dec 13;9(1):137. doi: 10.1186/s13613-019-0611-y.
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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.
Claude Guerin, Pr principal investigator
Hôpital de la Croix-Rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATC then pressure support 7 cm H2O PEP 4 cm H2O and Pressure support 7 cm H2O PEP 4 cm H2O then ATC in people with Acute Respiratory Insufficiency, run by Hospices Civils de Lyon 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 7 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 18 Sep 2025. 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?
the power of work of breathing (time frame: 30 minutes after onset the ventilator strategy). 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 NCT02939963, 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 18 Sep 2025.