Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)

• Conditions: Respiratory Failure; Respiratory Distress Syndrome; Mechanical Ventilation Complication

• Registration Number: NCT03768232
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

Study Timeline

• Study First Submitted: 2018-11-14
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07
• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients younger than 18 years old
• expected clinical requiring of invasive MV for more than 36 hours

Exclusion Criteria

• neonates
• subjects with preexisting diagnoses of neuromuscular weakness
• diaphragm paresis
• chronic respiratory failure with ongoing requirement for invasive MV, or continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with likely death within 48 hours.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient	through study completion an average of 100 days	the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology

Secondary Outcome Measures

Name	Time	Method
evaluation of two different diaphragmatic thickening fraction formula (DTF)	through study completion an average of 100 days	evaluate the feasibility and clinical applicability of our formula for the calculation of DTF (mTdi-insp - mTdi-exp)/mTdi-med x 100, comparing it to the standard one (Tdi-insp - Tdi-exp)/Tdi-exp x 100.
evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient	through study completion an average of 100 days	evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days