Back to resultsMechanical Ventilation During Cardiopulmonary Bypass (VENICE)
Primary Purpose
Congenital Heart Disease, Mechanical Ventilation Complication, Cardiopulmonary Bypass
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ventilation during cardiopulmonary bypass
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease
Eligibility Criteria
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
Sites / Locations
- AOPadova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ventilated Group
Not-ventilated group
Arm Description
This group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered.
This group will not receive any kind of mechanical ventilation during cardiopulmonary byass. The ventilator will be switched off.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03629574
First Posted
June 19, 2018
Last Updated
August 12, 2018
Sponsor
Azienda Ospedaliera di Padova
1. Study Identification
Unique Protocol Identification Number
NCT03629574
Brief Title
Mechanical Ventilation During Cardiopulmonary Bypass
Acronym
VENICE
Official Title
Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera di Padova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Mechanical Ventilation Complication, Cardiopulmonary Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ventilated Group
Arm Type
Experimental
Arm Description
This group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered.
Arm Title
Not-ventilated group
Arm Type
No Intervention
Arm Description
This group will not receive any kind of mechanical ventilation during cardiopulmonary byass. The ventilator will be switched off.
Intervention Type
Procedure
Intervention Name(s)
Ventilation during cardiopulmonary bypass
Intervention Description
Mechanical ventilation during cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass
Description
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.
Time Frame
Baseline, and 6, 12, 24 and 48 hours after the surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
AOPadova
City
Padova
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Costantino Gallo
Phone
049 8214439
Email
ce.sperimentazione@aopd.veneto.it
12. IPD Sharing Statement
Learn more about this trial
Mechanical Ventilation During Cardiopulmonary Bypass
We'll reach out to this number within 24 hrs