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 designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe 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 acronymHFCV-PEARDS
Study objectivesTo 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) studiedAcute respiratory distress syndrome
InterventionWe 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 typeProcedure/Surgery
Primary outcome measureOxygenation 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 measures1. Duration of PICU stay
2. Morbidity/mortality in PICU
Overall study start date03/03/2012
Completion date01/12/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Month
Upper age limit15 Years
SexBoth
Target number of participants20
Key inclusion criteriaPatients aged >1 month and <15 years with a diagnosis of ARDS from the PICU at King Chulalongkorn Memorial University Hospital
Key exclusion criteria1. 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 enrolment03/03/2012
Date of final enrolment01/09/2014

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 logo "ROR" https://ror.org/05jd2pj53

Funders

Funder type

Research organisation

Ratchada Pisek Somphot Fund (Thailand)

No information available

Results and Publications

Intention to publish date05/10/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe article has been submitted for publication.
IPD sharing plan