Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation. (PMVS)

June 4, 2021 updated by: University Hospital, Bordeaux

Evaluation of a Relationship Between Driving Pressure in Pressure Support Ventilation (PSV) and Mechanical Ventilation Weaning Time on Post-ARDS Patients

With the birth of Mechanical Ventilation in the 1950s came the ventilation induced lung injuries (VILI). Numerous works have since then shown the benefit of "protective ventilation", notably by controlling the delivered tidal volume and pressures. However, as the respiratory condition improves and the weaning is started by shifting to Pressure Support Ventilation (PSV), these parameters stop being tightly controlled. This study aims to determine whether there is a relationship between the driving pressure measured in PSV and the weaning time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scientific justification :

As mechanical ventilation developed since the 1950s, researchers started to recognize characteristic lung disease associated with it, Nash et al giving an anatomopathological description of "Respiratory Lung" on post-mortem examination of lungs after mechanical ventilation in 1967 [2]. It progressively led to the concept of VILI and of the protective ventilation to minimize it, enhancing lower tidal volume and plateau pressure [3], controlled Driving Pressure < 15cmH2O[4], neuromuscular blockade[5] and prone positioning[6]. However, these parameters can only be controlled for sedated patients in Controlled Ventilation. As the respiratory conditions improve, the onset of spontaneous breathing uses PSV [7] but because pressure support is added to the inspiratory effort of the patient, tidal volume and driving pressure stop being tightly controlled. It is therefore possible for the driving pressure to be higher than 15 cmH2O in case of a major inspiratory effort. One ought to wonder whether a high driving pressure is associated with a prolonged weaning phase following a moderate to severe ARDS.

Strategy description:

Patients that enter the weaning phase following a moderate to severe ARDS equipped with a nasogastric allowing measures of EAdi will be included. Driving Pressure will be measured following the method used by Bellani et al [1]. A weaning test will be conducted daily.

Follow up description:

  • Daily measures of End Inspiratory Pressure with respiratory synchronisation optimised by use of EAdi
  • Daily spontaneous breathing trial using low levels of pressure support
  • Pplat, Respiratory System Compliance, Driving Pressure, PEEP, Tidal Volume will be monitored daily as well as clinical and other routine ventilatory data. Data concerning initial severity of ARDS, and duration of ARDS, controlled mechanical ventilation, sedation and neuromuscular blockade and date of first spontaneous breathing trial will be collected. A weaning test will be conducted daily.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in the thoracic resuscitation department of the Haut-Lévêque Hospital, Bordeaux University Hospital, who will be consecutive patients undergoing respiratory weaning following a moderate-to-severe ARDS according to the Berlin criteria, and not presenting the exclusion criteria mentioned above will be proposed the protocol.

Description

Inclusion Criteria:

  • Patient over 18 years old
  • Patients hospitalized in the ICU and who have suffered moderate to severe ARDS (Berlin criteria) equiped with nasogastric feeding tube allowing measures of Eadi

Exclusion Criteria:

  • COPD or measured or suspected auto-PEEP higher than 3 cmH2O at beginning of Pressure Support
  • Admission in the ICU more than 15 days before the initiation of weaning
  • Broncho-pleural leaks
  • ECMO
  • Pregnant woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental
Experimental group is composed by patients that enter the weaning phase following a moderate to severe Acute Respiratory Distress Syndrome (ARDS) equiped with a nasogastric allowing measures of Electrical Activity of diaphragm (EAdi) will be included. Driving Pressure will be measured following the method used by Bellani et al. A weaning test will be conducted daily.
Other: Experimental
  • Daily measures of End Inspiratory Pressure with respiratory synchronisation optimised by use of EAdi
  • Daily spontaneous breathing trial using low levels of pressure support
  • Pplat, Respiratory System Compliance, Driving Pressure, PEEP, Tidal Volume will be monitored daily as well as clinical and other routine ventilatory data. Data concerning initial severity of ARDS, and duration of ARDS, controlled mechanical ventilation, sedation and neuromuscular blockade and date of first spontaneous breathing trial will be collected. A weaning test will be conducted daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ventilation free days
Time Frame: at day 28 following the inclusion visit
Ventilation free days is defined by the first transition from mechanical controlled ventilation to pressure support ventilation following a moderate to severe ARDS.
at day 28 following the inclusion visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extubated patients
Time Frame: at day 7 after inclusion visit
Number of extubated patients at day 7 after inclusion
at day 7 after inclusion visit
Successful weaning test
Time Frame: from inclusion day to successful weaning test, up to 28 days
Time to first successful weaning test
from inclusion day to successful weaning test, up to 28 days
Compliance of the Respiratory System (CRS)
Time Frame: from inclusion day to day 7
Evolution of CRS value during the first 7 days of weaning.The evolution is considered favorable, when the increase is more than 15% during the first 7 days of weaning.
from inclusion day to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2019/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrome

Clinical Trials on Experimental

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings