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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03768232

Recruitment Status : Unknown

Verified December 2018 by Matteo Di Nardo, Bambino Gesù Hospital and Research Institute.
Recruitment status was: Not yet recruiting

First Posted : December 7, 2018

Last Update Posted : December 7, 2018

Sponsor:

Information provided by (Responsible Party):

Matteo Di Nardo, Bambino Gesù Hospital and Research Institute

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Respiratory Failure Respiratory Distress Syndrome Mechanical Ventilation Complication	Other: ultrasound asessment

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.

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	80 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients
Estimated Study Start Date :	January 1, 2019
Estimated Primary Completion Date :	January 1, 2020
Estimated Study Completion Date :	January 1, 2020

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

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.

Outcome Measures

Primary Outcome 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 Outcome 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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	up to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

all patient admitted in PICU

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications of 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.

Layout table for additonal information

Responsible Party:	Matteo Di Nardo, Principal investigator, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:	NCT03768232
Other Study ID Numbers:	001
First Posted:	December 7, 2018 Key Record Dates
Last Update Posted:	December 7, 2018
Last Verified:	December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Matteo Di Nardo, Bambino Gesù Hospital and Research Institute:


ultrasound assessment diaphragm disfuncion

Additional relevant MeSH terms:

Layout table for MeSH terms

Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency Lung Diseases	Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases

To Top