Mechanical Ventilator WeaningI-SWEARNCT05114551
ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
An observational study of Mechanical Ventilator Weaning and Predictive Value of Tests, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilator Weaning, Predictive Value of Tests, Ventilator Weaning
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2021to 28 Sep 2023
- Phase
- Observational
- 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
Study population: The patients included in this study will be all the patients hospitalized in our 2 intensive care units, under mechanical ventilation for at least 48h, meeting the criteria of weanability and for whom a T-piece SBT will be planned.
Who may be able to join
- Age > 18 years
- Invasive mechanical ventilation for at least 48 hours
- Criteria for ventilatory weaning are present
- T-piece spontaneous breathing trial planned
- Patients with a social security program
Who cannot join
- Patients already included in this study during the same stay in intensive care
- Resuscitation neuromyopathy defined by an MRC (Medical Research Council) score < 48/60
- Surgery planned within 72 hours
- Prolonged ventilatory weaning (>7 days after the first SBT)
- Patients with tracheostomy
- Patients with non-reintubation decision or terminal extubation
Show all 13Show fewer
- Brain damaged patients
- Patients with ECMO/ECLS
- Tetraplegic or paraplegic patients with lesion level higher than T8
- Nasotracheal intubated patients
- Pregnant or breastfeeding women
- Refusal to participate in the study (refusal by patient or family member/trusted person).
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
Jules Audard contact
France1 site, 1 recruiting
- Recruiting
CHU
Clermont-Ferrand, 63000
Jules Audard, jaudard@chu-clermontferrand.fr
About this study
Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.
Read the detailed description
In our intensive care units, when a patient does not have risk factors for extubation failure, SBT (Spontaneous Breathing Trial) in PSV (Pressure Support Ventilation) is usually performed first as recommended. If patient fails the first SBT in PSV or extubation, weaning is considered difficult (WIND study group AJRCCM 2017). In this case, the service protocol provides a T-piece SBT for the following SBT. In addition, this same protocol proposes to perform T-piece SBT from the first weaning event in patients with risk factors for WiPO (Weaning-induced Pulmonary Oedema), defined as obesity (BMI >30 kg/m2), COPD (Chronic Obstructive Pulmonary Disease) (suspected or known), or heart disease (structural [hypertrophic, dilated, valvular], functional [diastolic or systolic dysfunction], ischemic, or dysrhythmic).
Our study population concerns patients for whom a T-piece trial is performed according to the service protocol.
A patient is potentially includible in the study if he has been under mechanical ventilation for at least 48h and if he presents criteria of weanability with a planned T-piece SBT. As long as the inclusion and non-inclusion criteria are respected (see inclusion/non-inclusion criteria), clinical, biological and ultrasound data will be collected before and at the end of the ventilatory weaning test. If the patient fails the weaning test and/or is not extubated following the test, data from each new T-piece SBT will be collected within 7 days of inclusion.
The global management of the patient, before, during and after the inclusion of the patient in the study is the one usually practiced in our intensive care units, based on the national and international recommendations as well as the literature exposed in the protocol.
During the patient's stay in the ICU, data from the medical record will be collected (demographic, clinical, treatment, vital status,...). A follow-up at D7, D28 and D90 will be performed.
- Conditions
- Mechanical Ventilator Weaning, Predictive Value of Tests, Ventilator Weaning, Airway Extubation, Care Unit, Intensive, Critical Care
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.
Measured: 72 hours
Secondary outcomes (6)
Mortality at day 7, 28 and 90
Measured: 90 days
Length of stay in intensive care
Measured: 90 days
Number of days without mechanical ventilation from study inclusion to day 28
Measured: 28 days
Time frame and reasons for reintubation in case of failed extubation.
Measured: 28 days
Use of non-invasive post-extubation ventilation
Measured: 7 days
Use of High Flow Nasal Oxygenation post-extubation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start28 Sep 2021
- Primary completion28 Sep 2023 (estimated)
- Study completion28 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114551
- Sponsor's protocol ID
- I -Swear (RNI 2021 AUDARD)
- Acronym
- I-SWEAR
- Status last verified
- Jan 2023
- First submitted
- 29 Oct 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
- ClinicalTrials.gov ID
- NCT05114551
- Acronym / sponsor ID
- I-SWEAR / I -Swear (RNI 2021 AUDARD)
- Conditions
- Mechanical Ventilator Weaning, Predictive Value of Tests, Ventilator Weaning, Airway Extubation, Care Unit, Intensive, Critical Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 28 Sep 2023 (estimated)
- First posted
- 10 Nov 2021 (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.
Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.
Detailed description
In our intensive care units, when a patient does not have risk factors for extubation failure, SBT (Spontaneous Breathing Trial) in PSV (Pressure Support Ventilation) is usually performed first as recommended. If patient fails the first SBT in PSV or extubation, weaning is considered difficult (WIND study group AJRCCM 2017). In this case, the service protocol provides a T-piece SBT for the following SBT. In addition, this same protocol proposes to perform T-piece SBT from the first weaning event in patients with risk factors for WiPO (Weaning-induced Pulmonary Oedema), defined as obesity (BMI >30 kg/m2), COPD (Chronic Obstructive Pulmonary Disease) (suspected or known), or heart disease (structural [hypertrophic, dilated, valvular], functional [diastolic or systolic dysfunction], ischemic, or dysrhythmic).
Our study population concerns patients for whom a T-piece trial is performed according to the service protocol.
A patient is potentially includible in the study if he has been under mechanical ventilation for at least 48h and if he presents criteria of weanability with a planned T-piece SBT. As long as the inclusion and non-inclusion criteria are respected (see inclusion/non-inclusion criteria), clinical, biological and ultrasound data will be collected before and at the end of the ventilatory weaning test. If the patient fails the weaning test and/or is not extubated following the test, data from each new T-piece SBT will be collected within 7 days of inclusion.
The global management of the patient, before, during and after the inclusion of the patient in the study is the one usually practiced in our intensive care units, based on the national and international recommendations as well as the literature exposed in the protocol.
During the patient's stay in the ICU, data from the medical record will be collected (demographic, clinical, treatment, vital status,...). A follow-up at D7, D28 and D90 will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in this study will be all the patients hospitalized in our 2 intensive care units, under mechanical ventilation for at least 48h, meeting the criteria of weanability and for whom a T-piece SBT will be planned.
Key inclusion criteria (5 listed)
- Age > 18 years
- Invasive mechanical ventilation for at least 48 hours
- Criteria for ventilatory weaning are present
- T-piece spontaneous breathing trial planned
- Patients with a social security program
Key exclusion criteria (13 listed)
- Patients already included in this study during the same stay in intensive care
- Resuscitation neuromyopathy defined by an MRC (Medical Research Council) score < 48/60
- Surgery planned within 72 hours
- Prolonged ventilatory weaning (>7 days after the first SBT)
- Patients with tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.
Time frame: 72 hours
6 secondary outcomes
Mortality at day 7, 28 and 90
Time frame: 90 days
Length of stay in intensive care
Time frame: 90 days
Number of days without mechanical ventilation from study inclusion to day 28
Time frame: 28 days
Time frame and reasons for reintubation in case of failed extubation.
Time frame: 28 days
Use of non-invasive post-extubation ventilation
Time frame: 7 days
Use of High Flow Nasal Oxygenation post-extubation
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Related trials for Mechanical Ventilator Weaning
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care
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.
Jules Audard contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilator Weaning and Predictive Value of Tests, run by University Hospital, Clermont-Ferrand 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 13 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation. (time frame: 72 hours). 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 31 Jan 2023.