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

Overview

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

Full Title of Study: “Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2020

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

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient
    • Time Frame: 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 Measures

  • evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
    • Time Frame: through study completion an average of 100 days
    • evaluation 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)
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 28 Days

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bambino Gesù Hospital and Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Matteo Di Nardo, Principal investigator – Bambino Gesù Hospital and Research Institute

Citations Reporting on Results

Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.

Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.

Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

Francis CA, Hoffer JA, Reynolds S. Ultrasonographic Evaluation of Diaphragm Thickness During Mechanical Ventilation in Intensive Care Patients. Am J Crit Care. 2016 Jan;25(1):e1-8. doi: 10.4037/ajcc2016563.

Glau CL, Conlon TW, Himebauch AS, Yehya N, Weiss SL, Berg RA, Nishisaki A. Progressive Diaphragm Atrophy in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2018 May;19(5):406-411. doi: 10.1097/PCC.0000000000001485.

Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.

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