Lung Protection and Pediatric Cardiac Surgery

NCT ID: NCT03023670

Last Updated: 2018-12-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-04-30

Brief Summary

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The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system

Detailed Description

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The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:

Conditions

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Lung Injury, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

cardiopulmonary bypass

Intervention Type PROCEDURE

Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass

Group B

This group will receive low rate (4\\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.

Group Type ACTIVE_COMPARATOR

cardiopulmonary bypass

Intervention Type PROCEDURE

Low rate (4\\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.

Interventions

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cardiopulmonary bypass

Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass

Intervention Type PROCEDURE

cardiopulmonary bypass

Low rate (4\\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.

Intervention Type PROCEDURE

Other Intervention Names

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Control group Low frequency group

Eligibility Criteria

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Inclusion Criteria

* Elective cardiac surgery
* Ventricular septal defect (VSD).
* Atrial septal defect (ASD)

Exclusion Criteria

* Cyanotic heart disease.
* Patients with preoperative chest problems.
* Patients with known renal or hepatic dysfunctions.
* Planned off-pump cardiac surgery.
* Emergency cardiac surgery.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate profossor of anesthesiology and critical care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayed Abd-Elshafy, M.D

Role: PRINCIPAL_INVESTIGATOR

Associate profossor of Anesthesiology and critical care

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB0000871180

Identifier Type: -

Identifier Source: org_study_id

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