Condition category
Respiratory
Date applied
14/03/2015
Date assigned
19/10/2015
Last edited
19/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute respiratory distress syndrome (ARDS) is a life-threatening medical condition where the lungs can't provide enough oxygen for the rest of the body. If someone develops ARDS, they are put on a mechanical ventilator to assist their breathing. High frequency oscillation ventilation (HFOV) is an alternative to conventional mechanical ventilation (CMV) to treat patients with severe ARDS. The aim of this study is to compare the effectiveness of HFOV and CMV in children with severe ARDS.

Who can participate?
Patients aged between 1 month and 15 years with a diagnosis of ARDS at King Chulalongkorn Memorial University Hospital.

What does the study involve?
Participants will be randomly allocated to be treated with either HFOV or CMV.

What are the possible benefits and risks of participating?
The results of this study will help us to identify groups of ARDS patients who can benefit from using either HFOV or CMV.

Where is the study run from?
King Chulalongkorn Memorial University Hospital (Thailand).

When is the study starting and how long is it expected to run for?
From March 2012 to February 2014.

Who is funding the study?
Ratchada Pisek Somphot Fund.

Who is the main contact?
Prof Rujipat Samransamruajkit
rujipatrs@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rujipat Samransamruajkit

ORCID ID

Contact details

Pediatric Critical Care Division
Department of Pediatrics
King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand
+66 (0)2 256 4951
Rujipat.S@chula.ac.th

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The clinical efficacy of high frequency ventilation compared with conventional ventilation with lung volume recruitment in severe pediatric acute respiratory distress syndrome: a randomized controlled trial

Acronym

HFCV-PEARDS

Study hypothesis

To determine the efficacy of lung volume recruitment maneuver (LVRM) with high frequency oscillatory ventilation (HFOV) and continuous mandatory ventilation (CMV) on oxygenation, hemodynamic alteration and clinical outcome in children with severe acute respiratory distress syndrome (ARDS).

Ethics approval

Ethics committee at King Chulalongkorn University, 30/03/2012, ref: 154/55

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute respiratory distress syndrome

Intervention

We performed a randomized controlled trial enrolling pediatric patients (aged 1 month to 15 years from March 2012 to September 2014) who were diagnosed to have severe ARDS upon PICU admission. Informed consent was obtained from the parents prior to their evaluation for HFOV therapy. Before randomization to the treatment arms, all patients were received CMV with the FiO2 of 1, the median PEEP of 12 cmH2O, fluid resuscitation to keep high CVP (range between 8-12 mmHg) and were mostly on either inotropics or vasopressors at the time of LVRM with either CMV or HFOV. All patients were deeply sedated and paralyzed. Patients were randomized to the LVRM protocol combined with either HFOV or CMV. Baseline characteristic data, oxygenation, hemodynamic parameters and clinical outcomes were recorded during the procedure and at 1, 4, 12, 24, 48 and 72 hours after LVRM.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Oxygenation response, PaO2/FiO2, Oxygen index, A-a gradient compare Pre-post lung volume recruitment. Timepoints: baseline, 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after lung volume recruitment.

Secondary outcome measures

1. Duration of PICU stay
2. Morbidity/mortality in PICU

Overall trial start date

03/03/2012

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged >1 month and <15 years with a diagnosis of ARDS from the PICU at King Chulalongkorn Memorial University Hospital

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Evidence/suspicion of congestive heart failure
2. Evidence of left atrial hypertension
3. Severe irreversible neurological injury or Intractable shock
4. The underlying disease was deemed irreversible or ARDS > 48 hours
5. Pre-existing air leak syndrome (e.g., pneumothorax or pneumomediastinum) or pre-existing cystic lung disease

Recruitment start date

03/03/2012

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Thailand

Trial participating centre

King Chulalongkorn University Hospital
Bangkok
10330
Thailand

Sponsor information

Organisation

King Chulalongkorn Memorial Hospital

Sponsor details

1873 Rama 4 Road
Bangkok
10330
Thailand
+66 (0)2 256 4951
Rujipat.S@chula.ac.th

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Ratchada Pisek Somphot Fund (Thailand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The article has been submitted for publication.

Intention to publish date

05/10/2015

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes