Aortic Cross Clamping Time, and Postoperative Respiratory Function

March 7, 2017 updated by: Emad Zarief , MD, Assiut University

Implication of Aortic Cross Clamping Time Upon Postoperative Respiratory Function in Adult Patients Undergoing Open Heart Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Emad Zarief Kamel Said

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group S
short time <90 m aortic cross clamping
Procedure: aortic cross clamping
duration of cross clamping, less than 90 minutes, or more than 90 minutes
Active Comparator: group L
> 90 minutes aortic cross clamping
Procedure: aortic cross clamping
duration of cross clamping, less than 90 minutes, or more than 90 minutes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to extubation
Time Frame: 24 hours postoperative
time to extubate in minutes
24 hours postoperative
ventilation
Time Frame: 48 hours postoperative
respiratory rate (breath/minute)
48 hours postoperative
carbon dioxide
Time Frame: 48 hours
PaCO2 mmhg
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Emad Z kamel Said, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

April 20, 2016

Study Completion (Actual)

August 25, 2016

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00009915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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