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OpenTrials
Completed

NCT Number: NCT03504176

Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

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.

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fulfill criteria for PARDS
  • mechanically ventilated

Exclusion criteria

  • perinatal lung disease

Treatment and study plan

Ventilation bundle

Other

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

Primary outcomes

  1. mortality

    Time frame: up to 60 days

    death during PICU stay

Secondary outcomes

  1. ventilator free days

    Time frame: up to 28 days

    days alive and free from mechanical ventilation

  2. PICU free days

    Time frame: up to 28 days

    days alive and discharged from PICU

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

Pediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2018
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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