Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03504176
Collaborator
(none)
134
1
25.2
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ventilation bundle

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 Design

Study Type:
Observational
Actual Enrollment :
134 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study
Actual Study Start Date :
Apr 6, 2018
Actual Primary Completion Date :
May 12, 2020
Actual Study Completion Date :
May 12, 2020

Arms and Interventions

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

Control

Standard of care prior to implementation of the ventilation bundle

Outcome Measures

Primary Outcome Measures

  1. mortality [up to 60 days]

    death during PICU stay

Secondary Outcome Measures

  1. ventilator free days [up to 28 days]

    days alive and free from mechanical ventilation

  2. PICU free days [up to 28 days]

    days alive and discharged from PICU

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • fulfill criteria for PARDS

  • mechanically ventilated

Exclusion Criteria:
  • perinatal lung disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Women's and Children's Hospital Singapore Singapore 229899

Sponsors and Collaborators

  • KK Women's and Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judith Wong Ju-Ming, Dr, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT03504176
Other Study ID Numbers:
  • 2017/3076
First Posted:
Apr 20, 2018
Last Update Posted:
May 20, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2020