Subcutaneous NTG for US Radial Artery Cannulation

NCT ID: NCT03006640

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

Group Type PLACEBO_COMPARATOR

Subcutaneous saline

Intervention Type DRUG

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

NTG group

Group Type ACTIVE_COMPARATOR

Subcutaneous nitroglycrin

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* morbid obese indicated for radial artery cannuulation

Exclusion Criteria

* +ve allen test peripheral arterial disease refusal
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AlRefaey Kandeel

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Refa-NTG-art

Identifier Type: -

Identifier Source: org_study_id