Mechanical Ventilation During Cardiopulmonary Bypass

NCT ID: NCT03629574

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Congenital Heart Disease Mechanical Ventilation Complication Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ventilated Group

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

Group Type EXPERIMENTAL

Ventilation during cardiopulmonary bypass

Intervention Type PROCEDURE

Mechanical ventilation during cardiopulmonary bypass

Not-ventilated group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ventilation during cardiopulmonary bypass

Mechanical ventilation during cardiopulmonary bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliera di Padova

OTHER

Sponsor Role lead

Responsible Party

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Cristiana Carollo

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOPadova

Padua, , Italy

Site Status

Countries

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Italy

Facility Contacts

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Costantino Gallo

Role: primary

049 8214439

Other Identifiers

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34365

Identifier Type: -

Identifier Source: org_study_id

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