Clinical trial NCT06420999: Incidence and Impact of ICU-acquired Diaphragm Weakness
Official title: Incidence and Impact of ICU-acquired Diaphragm Weakness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diaphragm Dysfunction
Keywords: ICU
diaphragmatic activity
Respiratory support
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90
timeFrame: 90 days after inclusion (+/- 15 days)
Secondary outcomes:
measure: Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).
timeFrame: The day of discharge from ICU
measure: Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.
timeFrame: The day of discharge from ICU
measure: Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.
timeFrame: The day of discharge from ICU
measure: Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.
timeFrame: 90 days after inclusion (+/- 15 days)
measure: Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay.
timeFrame: On the day ventilation is weaned
measure: Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions
timeFrame: 90 days after inclusion (+/- 15 days)
measure: Association between diaphragmatic dysfunction and the risk of respiratory complications at D90.
timeFrame: 90 days after inclusion (+/- 15 days)
Other outcomes:
Locations:
city: Paris
country: France
facility: Médecine intensive Réanimation
Study officials:
References: