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

Study Overview
=================
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.

Official Title
-----------------
Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients

Conditions
-----------------
Respiratory Failure, Respiratory Distress Syndrome, Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Other: ultrasound asessment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ultrasound asessment|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion an average of 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | through study completion an average of 100 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound assessment, diaphragm disfuncion