NCT03629574

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

June 19, 2018

Last Update Submit

August 12, 2018

Conditions

Congenital Heart DiseaseMechanical Ventilation ComplicationCardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Ventilated Group

EXPERIMENTAL

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

Procedure: Ventilation during cardiopulmonary bypass

Not-ventilated group

NO INTERVENTION

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

Interventions

Ventilation during cardiopulmonary bypassPROCEDURE

Mechanical ventilation during cardiopulmonary bypass

Ventilated Group

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • congenital heart diseases
  • younger than 5 years
  • CPB longer than 30 minutes in hypotermia
  • elective surgery
  • stable clinical conditions

You may not qualify if:

  • genetic anomalies
  • mechanical ventilation before the surgery
  • kidney injuries
  • hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOPadova

Padua, Italy

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 19, 2018

First Posted

August 14, 2018

Study Start

August 20, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

IT(1)