NCT03629574UnknownNot Applicable
Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas
Azienda Ospedaliera di Padova1 site in 1 country80 target enrollmentStarted: August 20, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass
Study Overview
Brief Summary
The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •congenital heart diseases
- •younger than 5 years
- •CPB longer than 30 minutes in hypotermia
- •elective surgery
- •stable clinical conditions
Exclusion Criteria
- •genetic anomalies
- •mechanical ventilation before the surgery
- •kidney injuries
- •hepatic failure
Outcomes
Primary Outcomes
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass
Time Frame: Baseline, and 6, 12, 24 and 48 hours after the surgery
It will be assed the plasma level of proteins which usually are absent in the plasma (surfactant protein A and B) that change as a damage of the air-blood membrane appears.
Secondary Outcomes
No secondary outcomes reported
Investigators
Cristiana Carollo
Medical Doctor
Azienda Ospedaliera di Padova
Study Sites (1)
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