Back to resultsLung Protection and Pediatric Cardiac Surgery
Primary Purpose
Lung Injury, Acute
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cardiopulmonary bypass
cardiopulmonary bypass
Sponsored by
About this trial
This is an interventional prevention trial for Lung Injury, Acute focused on measuring Lung, Cardiopulmonary Bypass, Pediatric, Cardiac surgery
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass
This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.
Outcomes
Primary Outcome Measures
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
Secondary Outcome Measures
Mechanical ventilation
Duration of mechanical ventilation (hours)
Intensive care unit stay
Intensive care unit stay
Intubation time
Intubation time (hours)
Arterial blood gases
Intraoperative and postoperative by appropriate scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03023670
Brief Title
Lung Protection and Pediatric Cardiac Surgery
Official Title
Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Acute
Keywords
Lung, Cardiopulmonary Bypass, Pediatric, Cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.
Intervention Type
Procedure
Intervention Name(s)
cardiopulmonary bypass
Other Intervention Name(s)
Control group
Intervention Description
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
Intervention Type
Procedure
Intervention Name(s)
cardiopulmonary bypass
Other Intervention Name(s)
Low frequency group
Intervention Description
Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
Primary Outcome Measure Information:
Title
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
Time Frame
preoperative and within the first 7 days postoperative
Secondary Outcome Measure Information:
Title
Mechanical ventilation
Description
Duration of mechanical ventilation (hours)
Time Frame
Within the first 7 days postoperative
Title
Intensive care unit stay
Description
Intensive care unit stay
Time Frame
Within the first 7 days postoperative
Title
Intubation time
Description
Intubation time (hours)
Time Frame
Within the first 7 days postoperative
Title
Arterial blood gases
Description
Intraoperative and postoperative by appropriate scale
Time Frame
Within the first 7 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed Abd-Elshafy, M.D
Organizational Affiliation
Associate profossor of Anesthesiology and critical care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Lung Protection and Pediatric Cardiac Surgery
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