Mechanical Ventilation During Cardiopulmonary Bypass

Not Applicable

• Conditions: Mechanical Ventilation Complication; Congenital Heart Disease; Cardiopulmonary Bypass
• Interventions: Procedure: Ventilation during cardiopulmonary bypass

• Registration Number: NCT03629574
• Lead Sponsor: Azienda Ospedaliera di Padova

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-19
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-12
• Last Update Submitted: 2018-08-12
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14
• Study Start: 2018-08-20
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventilated Group	Ventilation during cardiopulmonary bypass	This group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered.

Primary Outcome Measures

Name	Time	Method
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass	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.

Trial Locations

Locations (1)

AOPadova; 🇮🇹 Padova, Italy