Weaning Invasive Mechanical VentilationATARINCT06923267
Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
A study testing No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Pressure Support Spontaneous Breathing trial and Humidified High Flow Spontaneous Breathing Trial in people with Weaning Invasive Mechanical Ventilation and Weaning-induced Pulmonary Edema, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema, Weaning Failure of Mechanical Ventilation
- What is being tested?
- No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Pressure Support Spontaneous Breathing trial and Humidified High Flow Spontaneous Breathing Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
- Richmond Agitation Sedation Scale (RASS) between -1 and +1
- Patient at high risk of re-intubation with at least one of the following criteria:
- Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)
- Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease)
Who cannot join
- Neuromuscular pathology (myasthenia type) preceding hospitalization
- Pregnant or breast-feeding women
- Patient already included in the study
- Protected person (under guardianship or curatorship)
- Person under court protection
- Person not affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Orleans
Orléans, 45067
Guillaume Fossat, Pt, Msc, PhD Student, +33238651318, guillaume.fossat@chu-orleans.fr
Mai-Anh NAY, Dr
About this study
Official title: Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work.
Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others.
Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.
- Conditions
- Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema, Weaning Failure of Mechanical Ventilation, Spontaneous Breathing Test, Intensive Care Units (ICUs)
- Being tested
- No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Pressure Support Spontaneous Breathing trial, Humidified High Flow Spontaneous Breathing Trial
- Keywords
- Humidified high flow, Cardiac ultrasound, Spontaneous breathing trial, T-Piece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing TrialDiagnostic test
The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.
Pressure Support Spontaneous Breathing trialDiagnostic test
The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.
Humidified High Flow Spontaneous Breathing TrialDiagnostic test
The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.
| Study group | Role | What they receive |
|---|---|---|
| EVS1-EVS2-EVS3 (specific order of procedures) | Experimental | EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial Receives: Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial |
| EVS1-EVS3-EVS2 (specific order of procedures) | Experimental | EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial Receives: Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial |
| EVS2-EVS3-EVS1 (specific order of procedures) | Experimental | EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial Receives: Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial |
| EVS2-EVS1-EVS3 (specific order of procedures) | Experimental | EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial Receives: Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial |
| EVS3-EVS1-EVS2 (specific order of procedures) | Experimental | EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial Receives: Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial |
| EVS3-EVS2-EVS1 (specific order of procedures) | Experimental | EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial Receives: Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials.
An evaluator at the patient's bed will use the cardiac ultrasound probe. The patient will be installed in a semi-seated position and the E/E' index will be measured over 3 successive cardiac cycles if the patient is in sinus rhythm, or 5 successive cycles if the patient is in atrial fibrillation. The measurement is taken at the 5th minute of each spontaneous breathing trial. The cross-over order of trials will be randomized.
Once the cardiac ultrasound loops have been recorded, a blinded evaluator will read back the ultrasound images, and his or her measurement will be used for the primary evaluation.
Measured: At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start30 Apr 2025
- Primary completion9 Apr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Invasive 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923267
- Sponsor's protocol ID
- CHUO-2024-09
- Acronym
- ATARI
- Status last verified
- May 2026
- First submitted
- 10 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06923267
- Acronym / sponsor ID
- ATARI / CHUO-2024-09
- Conditions
- Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema, Weaning Failure of Mechanical Ventilation, Spontaneous Breathing Test, Intensive Care Units (ICUs)
- Keywords
- Humidified high flow, Cardiac ultrasound, Spontaneous breathing trial, T-Piece
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 Apr 2025 (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.
The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work.
Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others.
Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EVS1-EVS2-EVS3 (specific order of procedures) | Experimental | Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Diagnostic Test: Pressure Support Spontaneous Breathing trial, Diagnostic Test: Humidified High Flow Spontaneous Breathing TrialEVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial |
| EVS1-EVS3-EVS2 (specific order of procedures) | Experimental | Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Diagnostic Test: Pressure Support Spontaneous Breathing trial, Diagnostic Test: Humidified High Flow Spontaneous Breathing TrialEVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial |
| EVS2-EVS3-EVS1 (specific order of procedures) | Experimental | Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Diagnostic Test: Pressure Support Spontaneous Breathing trial, Diagnostic Test: Humidified High Flow Spontaneous Breathing TrialEVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial |
| EVS2-EVS1-EVS3 (specific order of procedures) | Experimental | Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Diagnostic Test: Pressure Support Spontaneous Breathing trial, Diagnostic Test: Humidified High Flow Spontaneous Breathing TrialEVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial |
| EVS3-EVS1-EVS2 (specific order of procedures) | Experimental | Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Diagnostic Test: Pressure Support Spontaneous Breathing trial, Diagnostic Test: Humidified High Flow Spontaneous Breathing TrialEVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial |
| EVS3-EVS2-EVS1 (specific order of procedures) | Experimental | Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Diagnostic Test: Pressure Support Spontaneous Breathing trial, Diagnostic Test: Humidified High Flow Spontaneous Breathing TrialEVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
- Richmond Agitation Sedation Scale (RASS) between -1 and +1
- Patient at high risk of re-intubation with at least one of the following criteria:
Key exclusion criteria (6 listed)
- Neuromuscular pathology (myasthenia type) preceding hospitalization
- Pregnant or breast-feeding women
- Patient already included in the study
- Protected person (under guardianship or curatorship)
- Person under court protection
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 |
|---|---|---|
| No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing TrialThe spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes. | Diagnostic test | EVS1-EVS2-EVS3 (specific order of procedures), EVS1-EVS3-EVS2 (specific order of procedures), EVS2-EVS1-EVS3 (specific order of procedures), EVS2-EVS3-EVS1 (specific order of procedures), EVS3-EVS1-EVS2 (specific order of procedures), EVS3-EVS2-EVS1 (specific order of procedures) |
| Pressure Support Spontaneous Breathing trialThe spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality. | Diagnostic test | EVS1-EVS2-EVS3 (specific order of procedures), EVS1-EVS3-EVS2 (specific order of procedures), EVS2-EVS1-EVS3 (specific order of procedures), EVS2-EVS3-EVS1 (specific order of procedures), EVS3-EVS1-EVS2 (specific order of procedures), EVS3-EVS2-EVS1 (specific order of procedures) |
| Humidified High Flow Spontaneous Breathing TrialThe spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality. | Diagnostic test | EVS1-EVS2-EVS3 (specific order of procedures), EVS1-EVS3-EVS2 (specific order of procedures), EVS2-EVS1-EVS3 (specific order of procedures), EVS2-EVS3-EVS1 (specific order of procedures), EVS3-EVS1-EVS2 (specific order of procedures), EVS3-EVS2-EVS1 (specific order of procedures) |
Primary outcome
Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials.
Time frame: At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)
An evaluator at the patient's bed will use the cardiac ultrasound probe. The patient will be installed in a semi-seated position and the E/E' index will be measured over 3 successive cardiac cycles if the patient is in sinus rhythm, or 5 successive cycles if the patient is in atrial fibrillation. The measurement is taken at the 5th minute of each spontaneous breathing trial. The cross-over order of trials will be randomized. Once the cardiac ultrasound loops have been recorded, a blinded evaluator will read back the ultrasound images, and his or her measurement will be used for the primary evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Pressure Support Spontaneous Breathing trial and Humidified High Flow Spontaneous Breathing Trial in people with Weaning Invasive Mechanical Ventilation and Weaning-induced Pulmonary Edema, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Fossat, Pt, Msc, PhD student (+33238651318, guillaume.fossat@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials. (time frame: At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.