Incidence and Impact of ICU-acquired Diaphragm Weakness
ConditionDiaphragm Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diaphragmatic ultrasound and data collection
Other interventionAt 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).
Treatment groups
194 Participants
are divided into 1 treatment groupGroup A: Patients weaned from mechanical or non invasive ventilation1 intervention
Trial outcomes
Primary outcomes
1
Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90
Mortality
Time frame
90 days after inclusion (+/- 15 days)Secondary outcomes
1
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
Time frame
The day of discharge from ICU2
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%.
Time frame
The day of discharge from ICU3
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
Time frame
The day of discharge from ICU4
Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.
Length of hospital stay
Time frame
90 days after inclusion (+/- 15 days)Sponsors and contacts
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Source ClinicalTrials.gov