Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

NCT03504176 | Completed

• 1 other identifier: 2017/3076
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations by the Pediatric Acute Lung Injury Consensus Conference (PALICC) are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high end expiratory pressure. A recent retrospective study of ventilation practices in Asia including Singapore showed that a majority of patients with PARDS were being ventilated with high tidal volume, high peak pressure and low end expiratory pressure, not in compliance with PALICC recommendations. We postulate that currently used ventilation strategies could have contributed to the high PARDS mortality rates in Asia. We aim to determine if implementing a ventilation bundle comprising PALICC recommendations lowers PARDS and pediatric intensive care unit (PICU) mortality rates.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• mortality

  death during PICU stay

  up to 60 days

Secondary Outcomes (2)

• ventilator free days

  up to 28 days

• PICU free days

  up to 28 days

Study Arms (2)

Intervention

Patients will be ventilated according to the bundle; including ventilation targets, tidal volume, end expiratory pressure-fraction of inspired oxygen titration.

Other: Ventilation bundle

Control

Standard of care prior to implementation of the ventilation bundle

Interventions

Ventilation bundle OTHER

ventilation targets (pH, spO2, pCO2) tidal volume 3-6ml/kg peak pressures \<28-32cmH2O PEEP-FiO2 titration tables

Intervention

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children admitted to the PICU needing mechanical ventilation will be screened for eligibility. Those who fulfill the PALICC criteria for PARDS will be included.

You may qualify if:

• fulfill criteria for PARDS
• mechanically ventilated

You may not qualify if:

• perinatal lung disease

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 20, 2018
• Study Start: April 6, 2018
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)