Diaphragm Dysfunction During Prolonged Mechanical Ventilation

NCT03676998 | Unknown

• 2 other identifiers: K171101J2017-A03091-52
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolonged Mechanical Ventilation

Keywords

Prolonged weaning; Diaphragm dysfunction; Liberation from mechanical

Outcome Measures

Primary Outcomes (1)

• Proportion of patients successfully liberated from the ventilator

  Liberation from the ventilator will be defined after 7 days of spontaneous

  After 7 days of spontaneous breathing

Secondary Outcomes (3)

• Diaphragm function

  Twice a week, up to 4 weeks

• Partial liberation from mechanical ventilation

  During hospitalization in Intensive Care Unit (ICU), up to 4 weeks

• Proportion of patients with diaphragm dysfunction upon admission and upon discharge

  From date of admission in ICU until the date of hospital discharge in ICU, assessed up to 4 weeks

Study Arms (1)

Measurement of diaphragm function

OTHER

Patients will be followed up from admission to weaning with twice a week a diaphragm function multimodal evaluation (ultrasound, phrenic nerves stimulation technique)

Device: Measurement of diaphragm function

Interventions

Measurement of diaphragm function DEVICE

A bilateral magnetic stimulation induces a non voluntary diaphragm contraction and a drop in airway pressure that is measured.

Measurement of diaphragm function

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old;
• Admission in weaning center;
• Tracheostomy;
• Ventilator dependence as defined by clinical intolerance criteria under spontaneous - breathing (Boles et al. ERJ 2017);
• Oral consent

You may not qualify if:

• Contre indication to the phrenic nerves stimulation technique (pace maker);
• Impossible liberation from the ventilator (degenerative neuromuscular diseases; high level spinal injury);
• Pregnancy;
• No insurance coverage

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Related Publications (1)

• Virolle S, Duceau B, Morawiec E, Fosse Q, Nierat MC, Parfait M, Decavele M, Demoule A, Delemazure J, Dres M. Contribution and evolution of respiratory muscles function in weaning outcome of ventilator-dependent patients. Crit Care. 2024 Dec 18;28(1):421. doi: 10.1186/s13054-024-05172-y.

  PMID: 39696360 DERIVED

Study Officials

• Martin DRES, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: September 19, 2018
• Study Start: February 22, 2019
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)