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Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03504176
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Judith Wong Ju-Ming, 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.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome 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).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : May 1, 2020

Group/Cohort Intervention/treatment
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

Standard of care prior to implementation of the ventilation bundle

Primary Outcome Measures :
  1. mortality [ Time Frame: up to 60 days ]
    death during PICU stay

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children admitted to the PICU needing mechanical ventilation will be screened for eligibility. Those who fulfill the PALICC criteria for PARDS will be included.

Inclusion Criteria:

  • fulfill criteria for PARDS
  • mechanically ventilated

Exclusion Criteria:

  • perinatal lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03504176

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Contact: Judith Wong, MBBCh BAO +6592355980

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KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Judith Wong, MBBCh BAO    +6592355980   
Sponsors and Collaborators
KK Women's and Children's Hospital

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Responsible Party: Judith Wong Ju-Ming, Dr, KK Women's and Children's Hospital Identifier: NCT03504176    
Other Study ID Numbers: 2017/3076
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury