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Lung Protection and Pediatric Cardiac Surgery

Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03023670
Enrollment
68
Registered
2017-01-18
Start date
2017-01-31
Completion date
2018-04-30
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Injury, Acute

Keywords

Lung, Cardiopulmonary Bypass, Pediatric, Cardiac surgery

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:

Interventions

PROCEDUREcardiopulmonary bypass

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperativepreoperative and within the first 7 days postoperative

Secondary

MeasureTime frameDescription
Mechanical ventilationWithin the first 7 days postoperativeDuration of mechanical ventilation (hours)
Intensive care unit stayWithin the first 7 days postoperativeIntensive care unit stay
Intubation timeWithin the first 7 days postoperativeIntubation time (hours)
Arterial blood gasesWithin the first 7 days postoperativeIntraoperative and postoperative by appropriate scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026