Subcutaneous NTG for US Radial Artery Cannulation (NTG-US-art)

December 27, 2016 updated by: AlRefaey Kandeel

Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients, difficult sampling and problems encountered with noninvasive blood pressure monitoring makes arterial cannulation an essential skill in many situations like surgeries or trans-radial procedures for coronary or carotid interventions.

Radial artery has been preferred over other sites for arterial cannulation due to low incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming to decrease insertion time, increase success rate and decrease related complications

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • morbid obese indicated for radial artery cannuulation

Exclusion Criteria:

  • +ve allen test peripheral arterial disease refusal

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Drug: Subcutaneous saline
In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
Active Comparator: NTG group
Drug: Subcutaneous nitroglycrin
In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate
Time Frame: 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

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

Sponsor

AlRefaey Kandeel

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

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 27, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Refa-NTG-art

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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