Mechanical Ventilation During Cardiopulmonary Bypass (VENICE)

U

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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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