Mechanical Ventilation During Cardiopulmonary Bypass (VENICE)

University of Padua

Status: Unknown

Conditions: Mechanical Ventilation Complication; Cardiopulmonary Bypass; Congenital Heart Disease

Treatments: Procedure: Ventilation during cardiopulmonary bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03629574

34365

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Ventilated Group

Experimental group

Description:

This group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered.

Treatment:

Procedure: Ventilation during cardiopulmonary bypass

Not-ventilated group

No Intervention group

Description:

This group will not receive any kind of mechanical ventilation during cardiopulmonary byass. The ventilator will be switched off.