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

Respiratory Failure Clinical Trial

— VIDD  

Official title:

Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03768232
• Other study ID #: 001
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: December 2018
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Complication
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

References & 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 Respi — View Citation

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. — View Citation

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. — View Citation

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 Atro — View Citation

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. — View Citation

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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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