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

Bambino Gesù Hospital and Research Institute80 enrolled

Overview

evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy

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 Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Failure Respiratory Distress Syndrome Mechanical Ventilation Complication

Interventions

ultrasound asessmentOTHER

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.

Eligibility

Sex: ALLMin age: 28 DaysMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient

the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology

Time frame: through study completion an average of 100 days

Secondary Outcomes

evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient

evaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days

Time frame: through study completion an average of 100 days

evaluation of two different diaphragmatic thickening fraction formula (DTF)

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.

Time frame: through study completion an average of 100 days

evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient

evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days

Time frame: through study completion an average of 100 days

Data from ClinicalTrials.gov

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