Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: Ventilation bundle

• Registration Number: NCT03504176
• Lead Sponsor: KK Women's and Children's Hospital

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.

Detailed Description

We implement a PARDS ventilation bundle compliant with PALICC recommendations. The bundle contains a daily checklist for ventilation targets and reference tables listing targeted tidal volumes and end expiratory pressure-fraction of inspired oxygen titration. We will recruit mechanically ventilated patients who meet PARDS criteria. After a one-month implementation period, we will collect patient data over the subsequent 18 months, and compare them with the corresponding data in the 24 months prior to the implementation. The primary outcome is PARDS mortality, defined as number of deaths out of PARDS cases. Secondary outcomes are feasibility of ventilation bundle implementation, ventilator (VFD) and intensive care unit (IFD) free days and PICU mortality (number of deaths out of PICU admissions).

Study Timeline

• Study Start: 2018-04-06
• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Status Verified: 2020-05
• Primary Completion: 2020-05-12
• Study Completion: 2020-05-12
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• fulfill criteria for PARDS
• mechanically ventilated

Exclusion Criteria

• perinatal lung disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
mortality	up to 60 days	death during PICU stay

Secondary Outcome Measures

Name	Time	Method
PICU free days	up to 28 days	days alive and discharged from PICU
ventilator free days	up to 28 days	days alive and free from mechanical ventilation

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore