Incidence and Impact of ICU-acquired Diaphragm Weakness

NCT ID: NCT06420999

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2028-01-29

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.

Detailed Description

Diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.

ICU discharge will be defined a priori using a checklist. Diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. Patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. The diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. These measurements will be taken at rest. Diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest.

Dyspnea will be assessed using a visual analog scale (VAS) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). It will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.

Conditions

Diaphragm Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Diaphragmatic ultrasound and data collection

Intervention Type: 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).

Interventions

Diaphragmatic ultrasound and data collection

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours.

3. Weaning from respiratory support (invasive or not) within the last 24 hours.

4. Patient (or trusted person/relative) informed and not opposed to the study.

Exclusion Criteria

1. Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.)

2. Patients with tracheostomy

3. Non-communicating patients

4. Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Médecine intensive Réanimation

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Martin Dres, MD,PHD

Role: CONTACT

martin.dres@aphp.fr

0142167809

Facility Contacts

Martin DRES, MD, PhD

Role: primary

martin.dres@aphp.fr

0142167809

Other Identifiers

APHP240248

Identifier Type: -

Identifier Source: org_study_id