Condition category
Respiratory
Date applied
21/08/2009
Date assigned
07/09/2009
Last edited
08/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rujipat Samransamruajkit

ORCID ID

Contact details

King Chulalongkorn Memorial Hospital
Pediatric Pulmonary & Critical Care
Praram 4 road
Pathum-one
Bangkok
10330
Thailand
+66 (0)2 256 4908
rujsam@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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)

Study design

Prospective interventional open label trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Oxygenation response, measured at 28 days in PICU

Secondary outcome measures

Mortality, measured at 28 days in PICU

Overall trial start date

01/01/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20 - 30 patients

Participant 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

Recruitment start date

01/01/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Thailand

Trial participating centre

King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand

Sponsor information

Organisation

Rachada Pisek Somphotch (Thailand)

Sponsor details

King Chulalongkorn Memorial Hospital
Praram 4 Road
Pathumone
Bangkok
10330
Thailand
+66 (0)2 256 4455
Jang_rung@hotmail.com

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Rachada Pisek Somphotch (Thailand) - Local University Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Viasys Healthcare (Thailand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes