Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420999
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-15
Brief Title:
Incidence and Impact of ICU-acquired Diaphragm Weakness
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Incidence and Impact of ICU-acquired Diaphragm Weakness
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRODIGY
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None