The use of high frequency oscillator ventilation (HFOV) in paediatric acute respiratory distress syndrome (ARDS) with open lung technique
| ISRCTN | ISRCTN19924570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19924570 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/08/2009
- Registration date
- 07/09/2009
- Last edited
- 08/09/2009
- 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
Not provided at time of registration
Contact information
Dr Rujipat Samransamruajkit
Scientific
Scientific
King Chulalongkorn Memorial Hospital
Pediatric Pulmonary & Critical Care
Praram 4 road, Pathum-one
Bangkok
10330
Thailand
| Phone | +66 (0)2 256 4908 |
|---|---|
| rujsam@hotmail.com |
Study information
| Study design | Prospective interventional open label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of high frequency oscillator ventilation (HFOV) in paediatric acute respiratory distress syndrome (ARDS) with open lung technique: a prospective, interventional open label trial |
| Study objectives | To determine the efficacy and feasibility of high frequency oscillator ventilation (HFOV) in children with acute respiratory distress syndrome (ARDS) by using HFOV combined with an open lung technique. |
| Ethics approval(s) | Approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Thailand, on the 5th April 2007 (ref: 236/2007; REC N0 002/50) |
| Health condition(s) or problem(s) studied | Paediatic acute respiratory distress syndrome (ARDS) |
| Intervention | Recruitment protocol: Body weight less than 35 kg (use of 3100 A): 1. Select patient (central line and/or arterial lines were placed prior to the manouevre) 2. Stable VS (optimised preload/use of inotrope) were required in all patients enrolling in the study. Start initial setting of HFOV, FiO2 1, MAP 30 cmH2O (turn piston off), 20 secs then gradually weaned MAP down to 5 - 8 cmH2O above previous conventional ventilator MAP (keep oxygen sat greater than 92%). Body weight greater than 35 kg (use of 3100B): 1. Select patient (central line and/or arterial line were placed prior to the recruitment manouevre) 2. Stable VS (optimised preload/use of inotrope/vasopressor) were required. Start initial setting of HFOV, FiO2 1, MAP 35 cmH2O (turn piston off), 30 seconds then gradually wean MAP down to 5 - 8 cmH2O above conventional ventilator. (Consider stopping procedure if unstable VS, BP drop and cannot correct by volume resuscitation or inotrope titration). The RMs can be repeated but not more than twice/day during the first 3 days if FiO2 could not weaned down more than 0.6, other ventilator adjustment was followed by the HFOV operation protocol. 3. If patients failed to keep oxygen saturation above 95% on the first trial of RM, repeat RM with raised mPaw to +3 cmH2O above the previous mPaw followed by weaning down the mPaw gradually every 3 - 5 minutes until it reached 5 - 8 cmH2O above the previous CV mPaw or the oxygen saturation start to drop below 95%. The RM will be done only in the first three days. Body weight less than 35 kg (use of 3100 A): 1. Select patient (central line and/or arterial line were placed prior to the recruitment manouevre) 2. Stable VS (optimised preload/use of inotrope) were required. (Consider stopping procedure if unstable VS, BP drop and could not correct by volume resuscitation or inotrope titration). The RMs were repeated but not more than twice/day during the first 3 days if FiO2 could not wean down more than 0.6, other ventilator adjustment were followed by HFOV our operation protocol. Also blood samples were collected at baseline, 1 hour after initial RM procedure and 24 hours thereafter. 3. Adjust other ventilator settings and wean were followed HFOV protocol or per PICU attendings. 4. The patients were switched back to CV mode if mPaw stay in the range of 22 - 24 cmH2O, on FiO2 equalling 0.4, or on HFOV greater than 24 hours and have overall clinical stable for more than 24 hours. 5. The patients were placed back on HFOV if intolerance to CV, e.g. oxygen saturation less than 88% was more than 15 minutes (FiO2 greater than 0.6) or Ph less than 7.3 and by greater than 0.1 from last HFOV value. Use of high frequency oscillator ventilation with open lung technique for the first three days. |
| Intervention type | Other |
| Primary outcome measure | Oxygenation response, measured at 28 days in PICU |
| Secondary outcome measures | Mortality, measured at 28 days in PICU |
| Overall study start date | 01/01/2007 |
| Completion date | 31/12/2008 |
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 - 30 patients |
| Key inclusion criteria | 1. Paediatric patients aged greater than 1 month to less than 15 years old (from January 2007 - November 2008), either sex 2. Diagnosis of ARDS within 72 hours of Paediatric Intensive Care Unit (PICU) admission 3. No exclusion criteria |
| Key exclusion criteria | 1. Pulmonary capillary wedge pressure greater than or equal to 18 mmHg 2. Evidence of left atrial hypertension 3. Severe irreversible neurological injury or intractable shock 4. The underlying disease was deemed irreversible or ARDS greater than 48 hours 5. Pre-existing air leak syndrome (e.g., pneumothorax or pneumomediastinum) 6. Pre-existing cystic lung disease |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Thailand
Study participating centre
King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand
10330
Thailand
Sponsor information
Rachada Pisek Somphotch (Thailand)
University/education
University/education
King Chulalongkorn Memorial Hospital
Praram 4 Road
Pathumone
Bangkok
10330
Thailand
| Phone | +66 (0)2 256 4455 |
|---|---|
| Jang_rung@hotmail.com |
Funders
Funder type
Industry
Rachada Pisek Somphotch (Thailand) - Local University Fund
No information available
Viasys Healthcare (Thailand)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
