Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

NCT ID: NCT03504176

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2020-05-12

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).

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

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

Ventilation bundle

Intervention Type: OTHER

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

No interventions assigned to this group

Interventions

Ventilation bundle

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• fulfill criteria for PARDS
• mechanically ventilated

Exclusion Criteria

• perinatal lung disease

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Judith Wong Ju-Ming

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2017/3076

Identifier Type: -

Identifier Source: org_study_id