Incidence and Impact of ICU-acquired Diaphragm Weakness

NCT06420999 | Recruiting

• 1 other identifier: APHP240248
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Furthermore, several studies have reported that the observation of impaired respiratory muscle function upon ICU discharge is associated with a poor long-term prognosis. However, the incidence and prognostic impact of persistent diaphragmatic dysfunction at ICU discharge have never been evaluated. The measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon ICU discharge. The hypothesis of the project is that the presence of ICU-acquired diaphragmatic dysfunction at ICU discharge is associated with a poorer prognosis within 90 days.

Conditions

Diaphragm Dysfunction

Keywords

ICU; diaphragmatic activity; Respiratory support

Outcome Measures

Primary Outcomes (1)

• Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90

  Mortality

  90 days after inclusion (+/- 15 days)

Secondary Outcomes (7)

• Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).

  The day of discharge from ICU

• Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.

  The day of discharge from ICU

• Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.

  The day of discharge from ICU

• Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.

  90 days after inclusion (+/- 15 days)

• Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay.

  On the day ventilation is weaned

Study Arms (1)

Patients weaned from mechanical or non invasive ventilation

Adults admitted to ICU receiving either invasive mechanical ventilation for at least 48 hours, non-invasive ventilation or high-flow humidified oxygen therapy for at least 48 hours, and who have been weaned from ventilatory support within the last 24 hours.

Other: Diaphragmatic ultrasound and data collection

Interventions

Diaphragmatic ultrasound and data collection OTHER

At the inclusion visit, anamnestic data available in the medical record and clinical data (vitals, chest X-ray) will be collected. At the same time, a diaphragmatic ultrasound will be performed in the half-seated position to measure diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm at rest. A follow-up visit will be made on the day of discharge from intensive care, during which diaphragmatic ultrasound will be performed At D90 (+/- 15 days), the following information will be collected by consulting the electronic medical record, or by telephone if the information is not available in the record: date of discharge from hospital, date of death, date and reason for readmission to hospital or intensive care, possible introduction of long-term non-invasive ventilation, new respiratory complication after discharge from intensive care (pneumonia, atelectasis).

Patients weaned from mechanical or non invasive ventilation

Eligibility Criteria

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

Study Population

The eligible population will be that of adult patients who have been in intensive care and have received invasive mechanical ventilation for at least 48 hours or non-invasive ventilation or humidified high-flow oxygen therapy for at least 48 hours, with a PaO2/FiO2 ratio \< 200 before ventilatory support was introduced.

You may qualify if:

• Age ≥ 18 years
• Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours.
• Weaning from respiratory support (invasive or not) within the last 24 hours.
• Patient (or trusted person/relative) informed and not opposed to the study.

You may not qualify if:

• Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.)
• Patients with tracheostomy
• Non-communicating patients
• Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Médecine intensive Réanimation

Paris, 75013, France

RECRUITING

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Martin Dres, MD,PHD

CONTACT

0142167809; martin.dres@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): January 29, 2028
• Study Completion (Estimated): January 29, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)