Interaction Diaphragm and Cardiac Function During Ventilator Weaning

NCT03486249 | Completed

• 1 other identifier: K180103J
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.

Conditions

Ventilator Weaning

Keywords

diaphragm dysfunction; ventilator weaning; pulmonary edema

Outcome Measures

Primary Outcomes (1)

• Failure at the spontaneous breathing trial

  Weaning failure defined by the criteria of the International Conference on Weaning (Boles et al. ERJ 2007)

  During or at the end of the spontaneous breathing trial

Secondary Outcomes (3)

• Rate of patients with diaphragm dysfunction

  At the end of the patient participation (Day 3)

• Rate of patients with weaning induced pulmonary edema

  At the end of the patient participation (Day 3)

• Rate of patients with diaphragm dysfunction and weaning induced pulmonary edema

  At the end of the patient participation (Day 3)

Study Arms (1)

Patient difficult to wean

EXPERIMENTAL

Repetition of medical examinations performed as part of the care. All patients will have a cardiac echo examination and diaphragm function assessment before the spontaneous breathing trial.

Other: Repetition of medical examinations performed as part of the care

Interventions

Repetition of medical examinations performed as part of the care OTHER

Cardiac echo, diaphragm ultrasound and phrenic nerves stimulation performed before the spontaneous breathing trial.

Patient difficult to wean

Eligibility Criteria

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

You may qualify if:

• Patients adult (age ≥ 18 years)
• Intubation and invasive mechanical ventilation longer than 48 hours;
• Failure to the first spontaneous breathing trial;
• Presence of weaning readiness criteria
• Oral informed consent
• Patient with affiliation to the french healthcare system

You may not qualify if:

• Pregnant women
• Patient opposition
• Contraindication to perform magnetic phrenic nerves stimulation technique (chest tube, cardiac pacemaker or implanted defibrillator, cervical implants, chest drains,...)
• Impossibility to consider ventilator weaning (total ventilator dependence : preexisting neuromuscular disorders, cervical spine injury…)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martin DRES, MD, PhD

  Assistance Publique Hoptiaux 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

Model Details: All patients will have a cardiac echo examination and diaphragm function assessment.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: April 27, 2018
• Primary Completion: April 30, 2018
• Study Completion: July 19, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

FR (1)