The clinical outcomes of using high frequency ventilation compared with conventional ventilation in children with severe respiratory failure

ISRCTN	ISRCTN64665281
DOI	https://doi.org/10.1186/ISRCTN64665281
Secondary identifying numbers	N/A

Submission date: 14/03/2015
Registration date: 19/10/2015
Last edited: 19/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Rujipat Samransamruajkit
Scientific

Pediatric Critical Care Division
Department of Pediatrics
King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand

Phone	+66 (0)2 256 4951
Email	Rujipat.S@chula.ac.th

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study acronym	HFCV-PEARDS
Study objectives	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(s)	Ethics committee at King Chulalongkorn University, 30/03/2012, ref: 154/55
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	03/03/2012
Completion date	01/12/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Upper age limit	15 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	Patients aged >1 month and <15 years with a diagnosis of ARDS from the PICU at King Chulalongkorn Memorial University Hospital
Key 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
Date of first enrolment	03/03/2012
Date of final enrolment	01/09/2014

Locations

Countries of recruitment

Thailand

Study participating centre

King Chulalongkorn University Hospital

Bangkok
10330
Thailand

Sponsor information

King Chulalongkorn Memorial Hospital
University/education

1873 Rama 4 Road
Bangkok
10330
Thailand

Phone	+66 (0)2 256 4951
Email	Rujipat.S@chula.ac.th
"ROR"	https://ror.org/05jd2pj53

Funders

Funder type

Research organisation

Ratchada Pisek Somphot Fund (Thailand)

No information available

Results and Publications

Intention to publish date	05/10/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	The article has been submitted for publication.
IPD sharing plan