An observational study in Acute Respiratory Distress Syndrome, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by University Hospital, Bordeaux · Observational
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.
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:
1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 548 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
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.
Time frame: at day 28 following the inclusion visit
Extubated patients
Number of extubated patients at day 7 after inclusion
Time frame: at day 7 after inclusion visit
Successful weaning test
Time to first successful weaning test
Time frame: from inclusion day to successful weaning test, up to 28 days
Compliance of the Respiratory System (CRS)
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.
Time frame: from inclusion day to day 7
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Mar 2021, 17 months.
Of 261 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 49. This study's 17 months is below that.
Counting every sponsor, half of 270 studies reached it within 24 months; a quarter within 11 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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