Incidence and Impact of ICU-acquired Diaphragm Weakness

Diaphragm Dysfunction Clinical Trial

— PRODIGY  

Official title:

Incidence and Impact of ICU-acquired Diaphragm Weakness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420999
• Other study ID #: APHP240248
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 16, 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Martin Dres, MD,PHD
• Phone: 0142167809
• Email: martin.dres[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 194
• Est. completion date: September 16, 2025
• Est. primary completion date: September 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Asthenia
• Diaphragm Dysfunction

Intervention

Other:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90	Mortality	90 days after inclusion (+/- 15 days)
Secondary	Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).	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	The day of discharge from ICU
Secondary	Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.	Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction<20%.	The day of discharge from ICU
Secondary	Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.	Clinically significant dyspnea defined by a VAS>3/10. Scale of 1 to 10 with 10 corresponding to minimal comfort	The day of discharge from ICU
Secondary	Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.	Length of hospital stay	90 days after inclusion (+/- 15 days)
Secondary	Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay.	Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction<20%.	On the day ventilation is weaned
Secondary	Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions	Percentage of readmissions to intensive care and hospital at D90.	90 days after inclusion (+/- 15 days)
Secondary	Association between diaphragmatic dysfunction and the risk of respiratory complications at D90.	The percentage of respiratory complications at D90, defined by the occurrence of pneumonia, reintubation, atelectasis (or worsening in case of pre-existing abnormality).	90 days after inclusion (+/- 15 days)