Trial Outcomes & Findings for Technique for Successful Ultrasound-guided Peripheral Vascular Access (NCT NCT01975974)

NCT ID: NCT01975974

Last Updated: 2017-05-30

Results Overview

we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI\>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

one day

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure
Ultrasound
Ultrasound guided peripheral vascular access Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients
Overall Study
STARTED
100
Overall Study
COMPLETED
100
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Technique for Successful Ultrasound-guided Peripheral Vascular Access

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ultrasound
n=100 Participants
Ultrasound guided peripheral vascular access Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients
Age, Continuous
60 years
STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male
Female
46 Participants
n=5 Participants
Sex: Female, Male
Male
54 Participants
n=5 Participants

PRIMARY outcome

Timeframe: one day

we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI\>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.

Outcome measures

Outcome measures
Measure
Ultrasound
n=100 Participants
Ultrasound guided peripheral vascular access Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients
Successful First Attempt Peripheral Venous Cannulation
96 participants

Adverse Events

Ultrasound

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ultrasound
n=100 participants at risk
Ultrasound guided peripheral vascular access Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients
Blood and lymphatic system disorders
IV infiltration
1.0%
1/100 • Number of events 1

Additional Information

Dr. Kenichi Ueda

University of Iowa Hospitals and Clinics

Phone: 319-356-2633

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place