Weaning of Mechanical VentilationWAVENCT05801692
Arterial Blood Gases in Weaning of Mechanical VEntilation
An observational study of Weaning of Mechanical Ventilation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Weaning of mechanical ventilation is an important phase of ICU (Intensive Care Unit) patient hospitalization. Patients have to pass a spontaneous breathing trial, can have a phase of pause with mechanical ventilation before extubation and then can be weaned of invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning of Mechanical Ventilation
- What is being tested?
- Weaning of mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2022to 1 Oct 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: Patients hospitalized in intensive care unit with invasive mechanical ventilation, first attempt of weaning of mechnical ventilation
Who may be able to join
- Older than 18 years
- first attempt of weaning of mechanical ventilation
Who cannot join
- withholding of life sustaining therapies
- spontaneous breathing trial unsuccessful
Trial locations and contacts
1 site in 1 country.
About this study
Weaning of mechanical ventilation is an important phase of ICU (Intensive Care Unit) patient hospitalization. Patients have to pass a spontaneous breathing trial, can have a phase of pause with mechanical ventilation before extubation and then can be weaned of invasive mechanical ventilation. Spontaneous breathing trial can be performed with a T-Tube or with Pressure support without PEEP (End Expiratory Positive Pressure) . Duration of spontaneous breathing trial range from 30 minutes to 120 minutes. Some clinicians performed an arterial blood gases at the end of the spontaneous breathing trial but this practice is not really defined and clearly explained in recommendations. Patients can benefit of ventilation support after extubation like non invasive pressure support or high flow nasal canulae. The procedure can be very different from a center to another, especially for arterial blood gases at the end of spontaneous breathing trial. Our aim is to observe in a multicenter study the daily practice of weaning of mechanical ventilation especially for arterial blood gases.
- Conditions
- Weaning of Mechanical Ventilation
- Being tested
- Weaning of mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning of mechanical ventilationProcedure or surgery
Weaning of mechanical ventilation is the time when the patient is ready for separation from ventilatory support until breathing without invasive support
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of spontaneous breathing trial performed
Spontaneous breathing trial is performed either with pressure support or with a T-Piece
Measured: In the 24 hours of spontaneous breathing trial
Secondary outcomes (9)
Arterial blood gases at the end of spontaneous breathing trial
Arterial blood gases are sometime performed at the end of the spontaneous breathing trial during weaning of mechanical ventilation. Spontaneous breathing trial takes from 30 to 120 minutes
Measured: In the hour of spontaneous breathing trial
Duration of spontaneous breathing trial
Duration in minutes
Measured: The day of the spontaneous breathing trial
Ventilatory procedure at the end of spontaneous breathing trial: either immediate extubation or pressure support ventilation with intubation
the procedure at the end of spontaneous: the patient is either extubated immediately or benefit of about one hour of invasive pressure support with the settings before spontaneous breathing trial until extubation. Procedure of extubation is differed of about one hour.
Measured: The day of extubation if extubation performed
Frequency and type of ventilatory support after extubation
Ventilatory is either not performed or if performed, with pressure support or high flow oxygen nasal canulae
Measured: The day of extubation if extubation performed
Need for reintubation
Reintubation is the need to reintubate the patient because of extubation failure
Measured: During the seven days following extubation
Etiology of reintubation
The cause of reintubation (pulmonary edema, infectious pulmonary disease...)
Measured: During the seven days following extubation
Death
If the patient died
Measured: The first 28 days following extubation
Ventilator associated pneumoniae
Pneumoniae acquired after more than 48 hours of mechanical ventilation
Measured: From 48 hours after extubation until extubation
days alive without mechanical ventilation
The number of days without invasive mechanical ventilation support during the first 28 days of intensive care hospitalization.
Measured: during the first 28 days of intensive care hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start21 Dec 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning of Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801692
- Sponsor's protocol ID
- CHUB WAVE
- Acronym
- WAVE
- Status last verified
- Jan 2023
- First submitted
- 10 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Blood Gases in Weaning of Mechanical VEntilation
- ClinicalTrials.gov ID
- NCT05801692
- Acronym / sponsor ID
- WAVE / CHUB WAVE
- Conditions
- Weaning of Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 6 Apr 2023 (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.
Weaning of mechanical ventilation is an important phase of ICU (Intensive Care Unit) patient hospitalization. Patients have to pass a spontaneous breathing trial, can have a phase of pause with mechanical ventilation before extubation and then can be weaned of invasive mechanical ventilation. Spontaneous breathing trial can be performed with a T-Tube or with Pressure support without PEEP (End Expiratory Positive Pressure) . Duration of spontaneous breathing trial range from 30 minutes to 120 minutes. Some clinicians performed an arterial blood gases at the end of the spontaneous breathing trial but this practice is not really defined and clearly explained in recommendations. Patients can benefit of ventilation support after extubation like non invasive pressure support or high flow nasal canulae. The procedure can be very different from a center to another, especially for arterial blood gases at the end of spontaneous breathing trial. Our aim is to observe in a multicenter study the daily practice of weaning of mechanical ventilation especially for arterial blood gases.
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
- Patients hospitalized in intensive care unit with invasive mechanical ventilation, first attempt of weaning of mechnical ventilation
Key inclusion criteria (2 listed)
- Older than 18 years
- first attempt of weaning of mechanical ventilation
Key exclusion criteria (2 listed)
- withholding of life sustaining therapies
- spontaneous breathing trial unsuccessful
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 |
|---|---|---|
| Weaning of mechanical ventilationWeaning of mechanical ventilation is the time when the patient is ready for separation from ventilatory support until breathing without invasive support | Procedure or surgery | – |
Primary outcome
Type of spontaneous breathing trial performed
Time frame: In the 24 hours of spontaneous breathing trial
Spontaneous breathing trial is performed either with pressure support or with a T-Piece
9 secondary outcomes
Arterial blood gases at the end of spontaneous breathing trial
Time frame: In the hour of spontaneous breathing trial
Duration of spontaneous breathing trial
Time frame: The day of the spontaneous breathing trial
Ventilatory procedure at the end of spontaneous breathing trial: either immediate extubation or pressure support ventilation with intubation
Time frame: The day of extubation if extubation performed
Frequency and type of ventilatory support after extubation
Time frame: The day of extubation if extubation performed
Need for reintubation
Time frame: During the seven days following extubation
Etiology of reintubation
Time frame: During the seven days following extubation
Death
Time frame: The first 28 days following extubation
Ventilator associated pneumoniae
Time frame: From 48 hours after extubation until extubation
days alive without mechanical ventilation
Time frame: during the first 28 days of intensive care hospitalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Weaning of Mechanical Ventilation, run by Centre Hospitalier Universitaire de Besancon 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 2 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 6 Apr 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?
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?
Type of spontaneous breathing trial performed (time frame: In the 24 hours of spontaneous breathing trial). 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 6 Apr 2023.