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