Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT03768232
Status:
UNKNOWN
Last Update Posted:
2018-12-07
First Post:
2018-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Study Overview
Official Title:
Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
NOT_YET_RECRUITING
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:
VIDD
Brief Summary:
evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy
Detailed Description:
Physician will perform US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.
Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.
Ventilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.
Extubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.
Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.
Ventilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.
Extubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.
Study Oversight
Has Oversight DMC:
False
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?: