Back to resultsSubcutaneous NTG for US Radial Artery Cannulation (NTG-US-art)
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subcutaneous nitroglycrin
Subcutaneous saline
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- morbid obese indicated for radial artery cannuulation
Exclusion Criteria:
- +ve allen test peripheral arterial disease refusal
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control group
NTG group
Arm Description
Outcomes
Primary Outcome Measures
Success rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03006640
Brief Title
Subcutaneous NTG for US Radial Artery Cannulation
Acronym
NTG-US-art
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
AlRefaey Kandeel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
NTG group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Subcutaneous nitroglycrin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Subcutaneous saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Success rate
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
morbid obese indicated for radial artery cannuulation
Exclusion Criteria:
+ve allen test peripheral arterial disease refusal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Subcutaneous NTG for US Radial Artery Cannulation
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