Skip to main content
OpenTrials
Completed

NCT Number: NCT04078984

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Haut-Lévêque

Pessac, 33604, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental

Other
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Extubated patients

    Time frame: at day 7 after inclusion visit

    Number of extubated patients at day 7 after inclusion

  2. Successful weaning test

    Time frame: from inclusion day to successful weaning test, up to 28 days

    Time to first successful weaning test

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: PMVS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.