Lung Protection and Pediatric Cardiac Surgery | NCT03023670

Studies
Lung Protection and Pediatric Cardiac Surgery

NCT03023670

Sponsor

Assiut University

Status

Completed

Last Update Posted

Dec 4, 2018Actual

Enrollment

68Actual

Phase

Not Applicable

Conditions

Lung Injury, Acute

Interventions

cardiopulmonary bypass
cardiopulmonary bypass

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 17, 2017

First Posted Date

Jan 18, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2018

Last Update Posted Date

Dec 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sayed Kaoud Abd-Elshafy, Associate profossor of anesthesiology and critical care, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass	Procedure: cardiopulmonary bypass
Group B	Active Comparator	This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.	Procedure: cardiopulmonary bypass

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiopulmonary bypass	Procedure	Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative		preoperative and within the first 7 days postoperative

Secondary Outcomes

Measure	Description	Time Frame
Mechanical ventilation	Duration of mechanical ventilation (hours)	Within the first 7 days postoperative
Intensive care unit stay	Intensive care unit stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sayed Abd-Elshafy, M.D	Associate profossor of Anesthesiology and critical care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002315	Cardiopulmonary Bypass
D035061	Control Groups

Ancestor Terms

ID	Term
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided