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

NCT04078984 | Completed

• 1 other identifier: CHUBX 2019/22
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Pressure Support Ventilation; Mechanical Ventilation Weaning Time; Driving Pressure; Respiratory Weaning; Acute Respiratory Distress Syndrome; Ventilation Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Ventilation free days

  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 Outcomes (3)

• Extubated patients

  at day 7 after inclusion visit

• Successful weaning test

  from inclusion day to successful weaning test, up to 28 days

• Compliance of the Respiratory System (CRS)

  from inclusion day to day 7

Study Arms (1)

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

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 6, 2019
• Study Start: September 27, 2019
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)