Lung Protection and Pediatric Cardiac Surgery

December 2, 2018 updated by: Sayed Kaoud Abd-Elshafy, Assiut University

Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass
Procedure: cardiopulmonary bypass
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
Other Names:
  • Control group
Procedure: cardiopulmonary bypass
Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
Other Names:
  • Low frequency group
Active Comparator: Group B
This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.
Procedure: cardiopulmonary bypass
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
Other Names:
  • Control group
Procedure: cardiopulmonary bypass
Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
Other Names:
  • Low frequency group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
Time Frame: preoperative and within the first 7 days postoperative
preoperative and within the first 7 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation
Time Frame: Within the first 7 days postoperative
Duration of mechanical ventilation (hours)
Within the first 7 days postoperative
Intensive care unit stay
Time Frame: Within the first 7 days postoperative
Intensive care unit stay
Within the first 7 days postoperative
Intubation time
Time Frame: Within the first 7 days postoperative
Intubation time (hours)
Within the first 7 days postoperative
Arterial blood gases
Time Frame: Within the first 7 days postoperative
Intraoperative and postoperative by appropriate scale
Within the first 7 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sayed Abd-Elshafy, M.D, Associate profossor of Anesthesiology and critical care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 2, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB0000871180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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