Extubation FailurePREDILACTNCT05487573
Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
An observational study of Extubation Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Extubation failure (EF) is independently associated with excess mortality of critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 15 Oct 2025
- 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: All patients hospitalized in intensive care, on invasive mechanical ventilation for more than 24 hours, and performing a spontaneous ventilation trial will be eligible for the study.
Who may be able to join
- Adult ≥ 18 years old
- Intubation and ventilation > 24 hours
Who cannot join
- Patients under guardianship or curators
- Opposition to participation in the study by the patient or family member
- Patients with tracheotomy
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
France1 site
Bichat - Claude-Bernard hospital
Paris, 75018
Alexu Tran Dinh, PhD, 1 40 25 83 54 ext. +33, alexy.trandinh@aphp.fr
About this study
Extubation failure (EF) is independently associated with excess mortality of critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator.
Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia.
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.
Read the detailed description
Extubation failure (EF) is defined as the need for reintubation within 48-72 hour. This complication is independently associated with a seven-fold increased risk of death in critically ill patients.
To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator. However, EF occurs in 10 to 20% of patients despite having successful SBT.
Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial.
Previous studies of predictive markers of EF have been performed primarily to assess weaning failure from cardiac origin.
The investigators hypothesize that critically ill patients who are going to have EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia, regardless of the cause of failure.
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.
- Conditions
- Extubation Failure
- Keywords
- Extubation failure, spontaneous breathing trial (SBT), lactatemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the variation in arterial lactate concentration
Evaluation of the variation in arterial lactate concentration measured before and after spontaneous ventilation trial in during weaning from invasive mechanical ventilation to predict extubation failure.
Measured: 72 hours
Secondary outcomes (3)
Arterial lactate concentration before the spontaneous ventilation trial
Measurement of arterial lactate concentration (mmol/L) before the spontaneous ventilation trial.
Measured: 30 minutes
Arterial lactate concentration after the spontaneous ventilation trial
Measurement of arterial lactate concentration (mmol/L) after the spontaneous ventilation trial and before reconnection to mechanical ventilation.
Measured: 30 minutes
Diagnostic performance of the variation in arterial lactate concentration
Calculation of the area under the receiver operating characteristic curves (AUROC) for the variation in arterial lactate concentration measured before and after spontaneous ventilation trial.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start15 Sep 2022 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexy Tran Dinh, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487573
- Sponsor's protocol ID
- 2022-A00111-42
- Acronym
- PREDILACT
- Status last verified
- Jul 2022
- First submitted
- 2 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
- ClinicalTrials.gov ID
- NCT05487573
- Acronym / sponsor ID
- PREDILACT / 2022-A00111-42
- Conditions
- Extubation Failure
- Keywords
- Extubation failure, spontaneous breathing trial (SBT), lactatemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 4 Aug 2022 (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.
Extubation failure (EF) is independently associated with excess mortality of critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator.
Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia.
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.
Detailed description
Extubation failure (EF) is defined as the need for reintubation within 48-72 hour. This complication is independently associated with a seven-fold increased risk of death in critically ill patients.
To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator. However, EF occurs in 10 to 20% of patients despite having successful SBT.
Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial.
Previous studies of predictive markers of EF have been performed primarily to assess weaning failure from cardiac origin.
The investigators hypothesize that critically ill patients who are going to have EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia, regardless of the cause of failure.
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized in intensive care, on invasive mechanical ventilation for more than 24 hours, and performing a spontaneous ventilation trial will be eligible for the study.
Key inclusion criteria (2 listed)
- Adult ≥ 18 years old
- Intubation and ventilation > 24 hours
Key exclusion criteria (4 listed)
- Patients under guardianship or curators
- Opposition to participation in the study by the patient or family member
- Patients with tracheotomy
- Pregnant or breast-feeding women
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
Evaluation of the variation in arterial lactate concentration
Time frame: 72 hours
Evaluation of the variation in arterial lactate concentration measured before and after spontaneous ventilation trial in during weaning from invasive mechanical ventilation to predict extubation failure.
3 secondary outcomes
Arterial lactate concentration before the spontaneous ventilation trial
Time frame: 30 minutes
Arterial lactate concentration after the spontaneous ventilation trial
Time frame: 30 minutes
Diagnostic performance of the variation in arterial lactate concentration
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Alexy Tran Dinh, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Extubation Failure, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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 15 Aug 2022. 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 Alexy Tran Dinh, PhD (1 40 25 83 54 ext. +33, alexy.trandinh@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the variation in arterial lactate concentration (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 15 Aug 2022.