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

Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03768232
Acronym
VIDD
Enrollment
80
Registered
2018-12-07
Start date
2019-01-01
Completion date
2020-01-01
Last updated
2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Respiratory Distress Syndrome, Respiratory Failure

Keywords

ultrasound assessment, diaphragm disfuncion

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.

Interventions

OTHERultrasound 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.

Sponsors

Bambino Gesù Hospital and Research Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patientthrough study completion an average of 100 daysthe assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology

Secondary

MeasureTime frameDescription
evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patientthrough study completion an average of 100 daysevaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days
evaluation of two different diaphragmatic thickening fraction formula (DTF)through study completion an average of 100 daysevaluate 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026