Incidence and Impact of ICU-acquired Diaphragm Weakness

Recruiting

• Conditions: Diaphragm Dysfunction
• Interventions: Other: Diaphragmatic ultrasound and data collection

• Registration Number: NCT06420999
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-20
• Status Verified: 2024-07
• Study Start: 2024-07-29
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-10-13
• Study Completion: 2025-10-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients weaned from mechanical or non invasive ventilation	Diaphragmatic ultrasound and data collection	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.

Primary Outcome Measures

Name	Time	Method
Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90	90 days after inclusion (+/- 15 days)	Mortality

Secondary Outcome Measures

Name	Time	Method
Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.	The day of discharge from ICU	Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction\<20%.
Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.	The day of discharge from ICU	Clinically significant dyspnea defined by a VAS\>3/10. Scale of 1 to 10 with 10 corresponding to minimal comfort
Association between diaphragmatic dysfunction and the risk of respiratory complications at D90.	90 days after inclusion (+/- 15 days)	The percentage of respiratory complications at D90, defined by the occurrence of pneumonia, reintubation, atelectasis (or worsening in case of pre-existing abnormality).
Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).	The day of discharge from ICU	Measurement of dyspnea on day of discharge from intensive care, assessed by visual analog scale (VAS). Scale of 1 to 10 with 10 corresponding to minimal comfort
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)	Length of hospital stay
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	Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction\<20%.
Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions	90 days after inclusion (+/- 15 days)	Percentage of readmissions to intensive care and hospital at D90.

Trial Locations

Locations (1)

Médecine intensive Réanimation; 🇫🇷 Paris, France