Mechanical Ventilation During Cardiopulmonary Bypass

Congenital Heart Disease Clinical Trial

— VENICE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03629574
• Other study ID #: 34365
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Azienda Ospedaliera di Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Congenital Heart Disease
• Heart Diseases
• Mechanical Ventilation Complication

Intervention

Procedure:
• Ventilation during cardiopulmonary bypass
Mechanical ventilation during cardiopulmonary bypass

Locations

Country	Name	City	State
Italy	AOPadova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass	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.	Baseline, and 6, 12, 24 and 48 hours after the surgery