Patient Mechanically Ventilated With APRV ModeNCT02866513
Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).
A study testing evaluate the variations of transpulmonary pressure during the use of APRV by clinicians. in people with Patient Mechanically Ventilated With APRV Mode, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Mechanically Ventilated With APRV Mode
- What is being tested?
- evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Mar 2017
- 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
- Adult
- Patient mechanically ventilated for more than 48 H for acute respiratory failure
- Decision to use of the APRV mode by clinicians in charge of the patient
Who cannot join
- Contraindication for the use of a nasogastric tube
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille hôpital de la Timone
Marseille, 13354
About this study
Official title: Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.
Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.
The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians
- Being tested
- evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.Other
| Study group | Role | What they receive |
|---|---|---|
| Patient mechanically ventilated with APRV mode | Other | Not described Receives: Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure
Measurement of transpulmonary pressure needs the measurement of oesophageal pressure with a specific nasogastric tube. This measurement is now available in routine in few mechanical ventilators in intensive care units (eg: AVEA Ventilator. Vyasys HealthCare). Transpulmonary pressure is the difference between airway pressure and oesophageal pressure and it is now easy to obtain and monitor at the bedside with these ventilators. It is also possible to record the value furthermore than 24 hours.
Measured: 24 hours
Secondary outcomes (1)
Maximal value of transpulmonary pressure
Value of tidal volume > 8 ml/kg
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Mechanically Ventilated With APRV ModeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866513
- Sponsor's protocol ID
- 2015-19
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.
- ClinicalTrials.gov ID
- NCT02866513
- Acronym / sponsor ID
- 2015-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Aug 2016 (estimated)
- 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.
Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.
The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient mechanically ventilated with APRV mode | Other | Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- Patient mechanically ventilated for more than 48 H for acute respiratory failure
- Decision to use of the APRV mode by clinicians in charge of the patient
Key exclusion criteria (1 listed)
- Contraindication for the use of a nasogastric tube
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 |
|---|---|---|
| evaluate the variations of transpulmonary pressure during the use of APRV by clinicians. | Other | Patient mechanically ventilated with APRV mode |
Primary outcome
Transpulmonary pressure
Time frame: 24 hours
Measurement of transpulmonary pressure needs the measurement of oesophageal pressure with a specific nasogastric tube. This measurement is now available in routine in few mechanical ventilators in intensive care units (eg: AVEA Ventilator. Vyasys HealthCare). Transpulmonary pressure is the difference between airway pressure and oesophageal pressure and it is now easy to obtain and monitor at the bedside with these ventilators. It is also possible to record the value furthermore than 24 hours.
1 secondary outcome
Maximal value of transpulmonary pressure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluate the variations of transpulmonary pressure during the use of APRV by clinicians. in people with Patient Mechanically Ventilated With APRV Mode, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 14 Nov 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transpulmonary pressure (time frame: 24 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 14 Nov 2017.