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Mechanical Ventilation During Cardiopulmonary Bypass

Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03629574
Acronym
VENICE
Enrollment
80
Registered
2018-08-14
Start date
2018-08-20
Completion date
2019-12-31
Last updated
2018-08-14

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

Conditions

Cardiopulmonary Bypass, Congenital Heart Disease, Mechanical Ventilation Complication

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

Interventions

Mechanical ventilation during cardiopulmonary bypass

Sponsors

Azienda Ospedaliera di Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypassBaseline, and 6, 12, 24 and 48 hours after the surgeryIt 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026