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Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03504176
Enrollment
134
Registered
2018-04-20
Start date
2018-04-06
Completion date
2020-05-12
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

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).

Interventions

OTHERVentilation bundle

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

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion criteria

* fulfill criteria for PARDS * mechanically ventilated

Exclusion criteria

* perinatal lung disease

Design outcomes

Primary

MeasureTime frameDescription
mortalityup to 60 daysdeath during PICU stay

Secondary

MeasureTime frameDescription
ventilator free daysup to 28 daysdays alive and free from mechanical ventilation
PICU free daysup to 28 daysdays alive and discharged from PICU

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026