NCT03676998: DD-SRPR

Diaphragm Dysfunction During Prolonged Mechanical Ventilation

Status unknown NA Last updated 28 March 2023

What this trial tests

NA trial testing Measurement of diaphragm function in Prolonged Mechanical Ventilation in 52 participants. Status unknown.

Timeline

22 February 2019

Primary endpoint
22 October 2024

22 October 2024

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	52
Start date	22 February 2019
Primary completion	22 October 2024
Estimated completion	22 October 2024
Sites	1 location across France

Drugs / interventions tested

• Measurement of diaphragm function

Conditions studied

• Prolonged Mechanical Ventilation — all drugs for Prolonged Mechanical Ventilation →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Prolonged Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Contribution and evolution of respiratory muscles function in weaning outcome of ventilator-dependent patients.
   Virolle S, Duceau B, Morawiec E, Fossé Q, et al · · 2024 · cited 5× · PMID 39696360 · DOI 10.1186/s13054-024-05172-y