A study to compare two medical devices during bypass in children.
- Conditions
- Health Condition 1: I999- Unspecified disorder of circulatory system
- Registration Number
- CTRI/2021/06/034500
- Lead Sponsor
- Artemis Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients meeting with following criteria to be included from the study:
1) Neonates of both gender.
2) Neonates who are scheduled to undergo cardiac surgery
involving cardiopulmonary bypass with CAPIOX FX05
integrated arterial filter oxygenator.
3) Legally acceptable representatives of neonates willing
to sign an Informed Consent Form indicating that they
understand the purpose of and the procedures required
for the study and are willing to participate in the
study.
Patients meeting with following criteria to be excluded from the study:
1) Neonates who are diagnosed with Cyanotic Heart Disease.
2) Neonates who are or will be on cardiopulmonary bypass for
more then 2 hours.
3) Presence of any other clinically significant disease or
laboratory findings that in the investigators opinion may
affect the study outcomes.
4) Participation in another study concurrently or within 4
weeks prior to the Screening visit.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method