A study to evaluate usefulness of biphasic extrathoracic cuirass ventilation (BCV) for acute respiratory failure in infants: A multicenter randomized controlled test with standard treatment as the control.
Not Applicable
- Conditions
- respiratory tract infection
- Registration Number
- JPRN-UMIN000015885
- Lead Sponsor
- Saitama Medical University Hospital department of Pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
Children requiring intratracheal intubation or mechanical ventilation (CMV: Conventional NPPV: Non-invasive Positive Pressure Ventilation) on admission. Children whose symptoms have been diagnosed as acute asthma attack. Children with circulatory failure. Children with primary disease (cyanotic heart disease, chronic lung disease, upper airway disease, thoracic deformity, cerebral palsy, congenital metabolic disorder). Severely multiple handicapped children. Children who were estimated not to be suitable for the study subjects by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of infants who required additional treatments, including mechanical ventilation (CMV, NPPV and BCV) due to respiratory distress induring 24 hours after treatent.
- Secondary Outcome Measures
Name Time Method Blood gas analysis at 1 hour after treatment. VAS(Visual analogue scale)1 hour after treatment. mPIS at 1,2 and 3 hours after treatment. mPIS at 24 hours after treatment. mPIS when BCV could be discontinued because of an improvement of symptoms. mPIS when the management by positive pressure ventilation was started because of worsening of symptoms. The frequency of additional treatments due to worsening of symptoms during the periods from the entrance to the end of the trial. Validity of of the timing to discontinue BCV. The number of infants BCV was restarted because of wosening of symptoms.