Lung Protection and Pediatric Cardiac Surgery
Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery
1 other identifier
interventional
68
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
1 active site
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
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedDecember 4, 2018
December 1, 2018
1.2 years
January 11, 2017
December 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
preoperative and within the first 7 days postoperative
Secondary Outcomes (4)
Mechanical ventilation
Within the first 7 days postoperative
Intensive care unit stay
Within the first 7 days postoperative
Intubation time
Within the first 7 days postoperative
Arterial blood gases
Within the first 7 days postoperative
Study Arms (2)
Group A
ACTIVE COMPARATORThis group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass
Group B
ACTIVE COMPARATORThis group will receive low rate (4\\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.
Interventions
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
Eligibility Criteria
You may qualify if:
- Elective cardiac surgery
- Ventricular septal defect (VSD).
- Atrial septal defect (ASD)
You may not qualify if:
- Cyanotic heart disease.
- Patients with preoperative chest problems.
- Patients with known renal or hepatic dysfunctions.
- Planned off-pump cardiac surgery.
- Emergency cardiac surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sayed Abd-Elshafy, M.D
Associate profossor of Anesthesiology and critical care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate profossor of anesthesiology and critical care
Study Record Dates
First Submitted
January 11, 2017
First Posted
January 18, 2017
Study Start
January 1, 2017
Primary Completion
March 1, 2018
Study Completion
April 1, 2018
Last Updated
December 4, 2018
Record last verified: 2018-12