Incidence and Impact of ICU-acquired Diaphragm Weakness

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 informatio

Первичные конечные точки

• Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90 [Срок оценки: 90 days after inclusion (+/- 15 days)]

Вторичные конечные точки (7)

• Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality). [Срок оценки: The day of discharge from ICU]
• Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care. [Срок оценки: The day of discharge from ICU]
• Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: On the day ventilation is weaned]
• Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions [Срок оценки: 90 days after inclusion (+/- 15 days)]
• Association between diaphragmatic dysfunction and the risk of respiratory complications at D90. [Срок оценки: 90 days after inclusion (+/- 15 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Médecine intensive Réanimation — Paris

Идентификаторы

NCT: NCT06420999 · APHP240248

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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