Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03023670
Other study ID # IRB0000871180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date April 2018

Study information

Verified date December 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system


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:


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 10 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
cardiopulmonary bypass
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
cardiopulmonary bypass
Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.

Locations

Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative preoperative and within the first 7 days postoperative
Secondary Mechanical ventilation Duration of mechanical ventilation (hours) Within the first 7 days postoperative
Secondary Intensive care unit stay Intensive care unit stay Within the first 7 days postoperative
Secondary Intubation time Intubation time (hours) Within the first 7 days postoperative
Secondary Arterial blood gases Intraoperative and postoperative by appropriate scale Within the first 7 days postoperative
See also
  Status Clinical Trial Phase
Completed NCT00498251 - Prevention of Lung Edema After Thoracic Surgery N/A
Completed NCT01597635 - The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury Phase 2
Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Completed NCT00996840 - SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS Phase 2
Completed NCT03651817 - Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg N/A
Recruiting NCT05680831 - Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air Phase 1
Completed NCT03764319 - Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO N/A
Completed NCT01640990 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers Phase 1
Completed NCT01114009 - Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients N/A
Terminated NCT00715338 - Effects of Oxygen on Lung Tissue During Anesthesia N/A
Recruiting NCT03202641 - Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients N/A
Completed NCT03828630 - Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients
Completed NCT03905837 - Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery Phase 4
Recruiting NCT05647967 - Features of Regional Perfusion of Lung Consolidation
Recruiting NCT04289324 - Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants N/A
Completed NCT05647382 - Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass N/A
Completed NCT05610475 - Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass N/A
Recruiting NCT04511923 - Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury Phase 1/Phase 2
Active, not recruiting NCT03637530 - a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries N/A
Completed NCT04344184 - SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI) Phase 2