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.

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. - RCT of BCV for acute respiratory failure in infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015885

Enrollment

Registered

2014-12-10

Start date

2015-10-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory tract infection

Interventions

Biphasic cuirass ventiration Control treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The criteria of subjects in the present study were as following; Less than 2 years old sPO2 level was between the value of 90% or more and less than 95%. Those who were diagnosed as respiratory diseases including bronchitis, pneumonia, bronchiolitis and so on. A written consent was obtained from the guardian.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYutaka Ueda

Saitama Medical University Hospital Pediatrics

y_ueda@saitama-med.ac.jp049-276-1218

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026