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Lung Protection and Pediatric Cardiac Surgery

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03023670
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
14.9
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: cardiopulmonary bypass
  • Procedure: cardiopulmonary bypass
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative [preoperative and within the first 7 days postoperative]

    Secondary Outcome Measures

    1. Mechanical ventilation [Within the first 7 days postoperative]

      Duration of mechanical ventilation (hours)

    2. Intensive care unit stay [Within the first 7 days postoperative]

      Intensive care unit stay

    3. Intubation time [Within the first 7 days postoperative]

      Intubation time (hours)

    4. Arterial blood gases [Within the first 7 days postoperative]

      Intraoperative and postoperative by appropriate scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sayed Kaoud Abd-Elshafy, Associate profossor of anesthesiology and critical care, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03023670
    Other Study ID Numbers:
    • IRB0000871180
    First Posted:
    Jan 18, 2017
    Last Update Posted:
    Dec 4, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Sayed Kaoud Abd-Elshafy, Associate profossor of anesthesiology and critical care, Assiut University
    Lung
    Cardiopulmonary Bypass
    Pediatric
    Cardiac surgery
    Additional relevant MeSH terms:
    Lung Injury
    Acute Lung Injury

    Study Results

    No Results Posted as of Dec 4, 2018