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

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ClinicalTrials.gov Identifier: NCT04078984
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Other: Experimental

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Relationship Between Driving Pressure in Pressure Support Ventilation (PSV) and Mechanical Ventilation Weaning Time on Post-ARDS Patients
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078984


Contacts
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Contact: Hadrien ROZE, Dr 5 57 65 68 66 ext +33 hadrien.roze@chu-bordeaux.fr
Contact: Jean De MONTAUDOIN jean.de-montaudouin@chu-bordeaux.fr

Locations
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France
Hôpital Haut-Lévêque Not yet recruiting
Pessac, France, 33604
Contact: Hadrien ROZE, Dr       hadrien.roze@chu-bordeaux.fr   
Contact: Jean De MONTAUDOIN       jean.de-montaudouin@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04078984     History of Changes
Other Study ID Numbers: CHUBX 2019/22
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Pressure Support Ventilation
Mechanical Ventilation Weaning Time
Driving Pressure
Respiratory Weaning
Acute Respiratory Distress Syndrome
Ventilation Induced Lung Injury
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury