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

NCT03768232 | Unknown

• 1 other identifier: 001
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Respiratory Failure; Respiratory Distress Syndrome; Mechanical Ventilation Complication

Keywords

ultrasound assessment; diaphragm disfuncion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient

  through study completion an average of 100 days

• evaluation of two different diaphragmatic thickening fraction formula (DTF)

  through study completion an average of 100 days

• evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient

  through study completion an average of 100 days

Interventions

ultrasound asessment OTHER

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 Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

all patient admitted in PICU

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Related Publications (6)

• 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.

  PMID: 23641946 RESULT

• 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.

  PMID: 21705883 RESULT

• 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.

  PMID: 18367735 RESULT

• 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.

  PMID: 26724302 RESULT

• 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.

  PMID: 29406380 RESULT

• 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.

  PMID: 28930478 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: December 7, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share