NCT03006640

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

December 27, 2016

Last Update Submit

December 27, 2016

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Success rate

    24 hours after surgery

Study Arms (2)

Control group

PLACEBO COMPARATOR
Drug: Subcutaneous saline

NTG group

ACTIVE COMPARATOR
Drug: Subcutaneous nitroglycrin

Interventions

Subcutaneous nitroglycrinDRUG

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
Subcutaneous salineDRUG

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

Control group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • morbid obese indicated for radial artery cannuulation

You may not qualify if:

  • +ve allen test peripheral arterial disease refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 27, 2016

First Posted

December 30, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

December 30, 2016

Record last verified: 2016-12