Aortic Cross Clamping Time, and Postoperative Respiratory... | NCT03072784

Studies
Aortic Cross Clamping Time, and Postoperative Respiratory Function

NCT03072784

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 9, 2017Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Bypass Complication
Respiratory Complication

Interventions

aortic cross clamping

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

Mar 2017

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

Feb 1, 2015Actual

Primary Completion Date

Apr 20, 2016Actual

Completion Date

Aug 25, 2016Actual

First Submitted Date

Feb 15, 2017

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 7, 2017Actual

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

Mar 7, 2017

Last Update Posted Date

Mar 9, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function.

Detailed Description

Cardiac surgery usually is done under cardiopulmonary bypass. As the blood contacts with the artificial tubing of the circuit, there is release of mediators which affects pulmonary function. Of no doubt that the duration of cardiopulmonary bypass, and cross clamping time, will affect the spell over of such mediators. Follow up of the pulmonary function, and arterial blood gas is mandatory in such group of patients.

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

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group S	Active Comparator	short time <90 m aortic cross clamping	Procedure: aortic cross clamping
group L	Active Comparator	> 90 minutes aortic cross clamping	Procedure: aortic cross clamping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aortic cross clamping	Procedure	duration of cross clamping, less than 90 minutes, or more than 90 minutes	group L group S

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of oxygenation	PaO2 mmHg	48 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
time to extubation	time to extubate in minutes	24 hours postoperative
ventilation	respiratory rate (breath/minute)	48 hours postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients
elective open heart surgery

Exclusion Criteria:

Patients with myocardial ischemia or previous infarction
low ejection fraction <30%
history of AF
implanted pacemaker
uncontrolled hypertension
renal impairment (creatinine >1.8 mg/dl)
hepatic dysfunction
insulin dependent diabetes
chronic pulmonary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emad Z kamel Said, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emad Zarief Kamel Said		Asyut	Asyut Governorate	71111	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