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Radial Artery Cannulation and Perfusion Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845361
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hany Mostafa Esmaeil Osman, Assiut University

Brief Summary:
This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.

Condition or disease Intervention/treatment Phase
Peripheral Perfusion Procedure: Radial artery cannulation Not Applicable

Detailed Description:

Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis.

Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion.

this study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Does Radial Artery Cannulation Affect the Perfusion of the Dominant Hand in Patients Undergoing Open Cardiac Surgery? Data Derived From the Peripheral Perfusion Index.
Actual Study Start Date : February 21, 2019
Actual Primary Completion Date : January 21, 2021
Estimated Study Completion Date : August 21, 2021

Arm Intervention/treatment
Experimental: C. hand
Radial artery cannulation
Procedure: Radial artery cannulation
Radial artery cannulation

No Intervention: N.C. hand
No cannulation of the radial artery



Primary Outcome Measures :
  1. The perfusion index [ Time Frame: Intraoperative ]
  2. The peripheral temperature [ Time Frame: Intraoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

  • Peripheral vascular diseases
  • previous upper limb surgeries
  • planned radial artery harvesting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845361


Contacts
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Contact: Hany M. Osman, M.D. +201002414591 hanymeo@aun.edu.eg
Contact: Fatma N. Mohamed, M.D. fatmanabil2012@gmail.com

Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Hany M. Osman, M.D.    +201002414591    hanymeo@gmail.com   
Contact: Fatma N. Mohamed, M.D.    +201003633992    fatmanabil2012@gmail.com   
Principal Investigator: Hany M. Osman, M.D.         
Principal Investigator: Fatma N. Mohamed, M.D.         
Principal Investigator: Mohamed Anwar, M.D.         
Sponsors and Collaborators
Assiut University
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Responsible Party: Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03845361    
Other Study ID Numbers: Radial perfusion index
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hany Mostafa Esmaeil Osman, Assiut University:
Perfusion index
Cardiac Surgery
Radial artery cannulation