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OpenTrials
Completed

NCT Number: NCT03023670

Lung Protection and 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

Completed

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Key information

Conditions

Lung Injury, Acute Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiopulmonary bypass

Procedure

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

Other names: Control group

Primary outcomes

  1. Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative

    Time frame: preoperative and within the first 7 days postoperative

Secondary outcomes

  1. Mechanical ventilation

    Time frame: Within the first 7 days postoperative

    Duration of mechanical ventilation (hours)

  2. Intensive care unit stay

    Time frame: Within the first 7 days postoperative

    Intensive care unit stay

  3. Intubation time

    Time frame: Within the first 7 days postoperative

    Intubation time (hours)

  4. Arterial blood gases

    Time frame: Within the first 7 days postoperative

    Intraoperative and postoperative by appropriate scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2017
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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