Noctural Ventilatory Mode and Weaning DurationREVENTIL 2NCT03428737
Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases
A study testing Pressure support ventilation in people with Noctural Ventilatory Mode and Weaning Duration, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noctural Ventilatory Mode and Weaning Duration
- What is being tested?
- Pressure support ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 Apr 2022
- 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
- Patient with invasive mechanical ventilation (with B840 ventilator)
- Patient with ventilation weaning criteria
- Patient able to support during the day pressure support ventilation with pressure support lower than 19 cm of H2O.
- Patient with all mechanical ventilation weaning criteria for the first trial of spontaneous ventilation.
- Age > 18 years
Who cannot join
- Patient with central apnoea syndrome
- Patient with narcolepsy
- Patient with metabolic encephalopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2
The weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator mode to use during the night. In weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement.
The main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. A secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.
Read the detailed description
All patients with weaning criteria, spontaneous breathing test will be done. If patient is able to have spontaneous ventilation with maximum of 16 cm of H2O of pressure support, he could be included in the study. The nocturnal ventilation mode will be randomised between pressure controlled ventilation and pressure support ventilation with the same pressure support than during the day. We will follow the quality and quantity of sleep with continue polysomnography. Indeed, patients in ICU could sleep during the night but too during the day. We will compare the duration of the weaning period between the two arms.
- Being tested
- Nocturnal controlled pressure control ventilation, Pressure support ventilation
- Keywords
- pressure support ventilation, pressure control ventilation, sleep, weaning, chronic obstructive respiratory disease, weaning duration period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal controlled pressure control ventilationProcedure or surgery
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
Pressure support ventilationProcedure or surgery
use of a pressure support level identical during the night to the pressure support level at the end of the day.
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal controlled pressure control ventilation | Other | use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night Receives: Procedure: Nocturnal controlled pressure control ventilation |
| Nocturnal pressure support ventilation | Other | Use of a pressure support level identical during the night to the pressure support level at the end of the day. Receives: Procedure: Pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of ventilation weaning at Day 4
Measured: at 4 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Mar 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Why it stopped: none participant included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noctural Ventilatory Mode and Weaning DurationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428737
- Sponsor's protocol ID
- PI2017_843_0016
- Acronym
- REVENTIL 2
- Status last verified
- May 2023
- First submitted
- 5 Feb 2018
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2
- ClinicalTrials.gov ID
- NCT03428737
- Acronym / sponsor ID
- REVENTIL 2 / PI2017_843_0016
- Keywords
- pressure support ventilation, pressure control ventilation, sleep, weaning, chronic obstructive respiratory disease, weaning duration period
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: none participant included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 12 Feb 2018 (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 weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator mode to use during the night. In weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement.
The main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. A secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.
Detailed description
All patients with weaning criteria, spontaneous breathing test will be done. If patient is able to have spontaneous ventilation with maximum of 16 cm of H2O of pressure support, he could be included in the study. The nocturnal ventilation mode will be randomised between pressure controlled ventilation and pressure support ventilation with the same pressure support than during the day. We will follow the quality and quantity of sleep with continue polysomnography. Indeed, patients in ICU could sleep during the night but too during the day. We will compare the duration of the weaning period between the two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nocturnal controlled pressure control ventilation | Other | Procedure: Nocturnal controlled pressure control ventilationuse of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night |
| Nocturnal pressure support ventilation | Other | Procedure: Pressure support ventilationUse of a pressure support level identical during the night to the pressure support level at the end of the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with invasive mechanical ventilation (with B840 ventilator)
- Patient with ventilation weaning criteria
- Patient able to support during the day pressure support ventilation with pressure support lower than 19 cm of H2O.
- Patient with all mechanical ventilation weaning criteria for the first trial of spontaneous ventilation.
- Age > 18 years
Key exclusion criteria (3 listed)
- Patient with central apnoea syndrome
- Patient with narcolepsy
- Patient with metabolic encephalopathy.
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 |
|---|---|---|
| Nocturnal controlled pressure control ventilationuse of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night | Procedure or surgery | Nocturnal controlled pressure control ventilation |
| Pressure support ventilationuse of a pressure support level identical during the night to the pressure support level at the end of the day. | Procedure or surgery | Nocturnal pressure support ventilation |
Primary outcome
The percentage of ventilation weaning at Day 4
Time frame: at 4 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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?
A study testing Pressure support ventilation in people with Noctural Ventilatory Mode and Weaning Duration, run by Centre Hospitalier Universitaire, Amiens 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 3 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: withdrawn, as of the sponsor's last update on 10 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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 percentage of ventilation weaning at Day 4 (time frame: at 4 day). 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 10 May 2023.