Trial Outcomes & Findings for The Effects of the STAR Maneuver on UGRA Training (NCT NCT02032420)

NCT ID: NCT02032420

Last Updated: 2017-02-13

Results Overview

Median time taken to complete 3 iterations of the assigned task, across participants within a study arm

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: Immediately after training
• Results posted on: 2017-02-13

Participant Flow

Participant milestones

Measure	STAR Strategy Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	ART Strategy Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
Overall Study STARTED	18	17
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of the STAR Maneuver on UGRA Training

Baseline characteristics by cohort

Measure	STAR Strategy n=18 Participants Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	ART Strategy n=17 Participants Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.	Total n=35 Participants Total of all reporting groups
Age, Continuous	21 years n=5 Participants	21 years n=7 Participants	21 years n=5 Participants
Gender Female	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Plays video games	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after training

Median time taken to complete 3 iterations of the assigned task, across participants within a study arm

Outcome measures

Measure	STAR Strategy n=18 Participants Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	ART Strategy n=17 Participants Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
Task Completion Time	87 seconds Interval 47.8 to 116.1	343 seconds Interval 214.0 to 600.0

SECONDARY outcome

Timeframe: During attempt

Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm

Outcome measures

Measure	STAR Strategy n=18 Participants Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	ART Strategy n=17 Participants Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
Needle-not-seen Time	42.8 percentage of attempt time Interval 32.3 to 68.9	68.7 percentage of attempt time Interval 64.6 to 75.1

SECONDARY outcome

Timeframe: During task

Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue

Outcome measures

Measure	STAR Strategy n=18 Participants Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	ART Strategy n=17 Participants Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
Performer Fatigue	1 units on a scale Interval 1.0 to 2.5	4.5 units on a scale Interval 1.0 to 9.0

POST_HOC outcome

Timeframe: Immediately after training

Some participants found the task too difficult to complete.

Outcome measures

Measure	STAR Strategy n=18 Participants Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	ART Strategy n=17 Participants Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
Inability to Complete Assigned Task at All in Three Attempts	0 participants	7 participants

Adverse Events

STAR Strategy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ART Strategy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicholas Lam

University of New Mexico

Phone: 505-272-2610

Email: nlam@salud.unm.edu

Results disclosure agreements

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