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
|Condition or disease||Intervention/treatment|
|Acute Respiratory Distress Syndrome||Other: Experimental|
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 . It progressively led to the concept of VILI and of the protective ventilation to minimize it, enhancing lower tidal volume and plateau pressure , controlled Driving Pressure < 15cmH2O, neuromuscular blockade and prone positioning. 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  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.
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 . 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 :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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.
- Extubated patients [ Time Frame: at day 7 after inclusion visit ]Number of extubated patients at day 7 after inclusion
- Successful weaning test [ Time Frame: from inclusion day to successful weaning test, up to 28 days ]Time to first successful weaning test
- 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.
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
|Contact: Hadrien ROZE, Dr||5 57 65 68 66 ext +email@example.com|
|Contact: Jean De MONTAUDOINfirstname.lastname@example.org|
|Hôpital Haut-Lévêque||Not yet recruiting|
|Pessac, France, 33604|
|Contact: Hadrien ROZE, Dr email@example.com|
|Contact: Jean De MONTAUDOIN firstname.lastname@example.org|