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 |
| Protocol serial number | N/A |
| Sponsor | King Chulalongkorn Memorial Hospital |
| Funder | Ratchada Pisek Somphot Fund (Thailand) |
- 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
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
Scientific
Pediatric Critical Care Division
Department of Pediatrics
King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand
| Phone | +66 (0)2 256 4951 |
|---|---|
| Rujipat.S@chula.ac.th |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Duration of PICU stay |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 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
10330
Thailand
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
