Trial Outcomes & Findings for Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique (NCT NCT02814721)

Results Overview

Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

3 weeks from use of fistula

Results posted on

2024-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Cannulation The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.	Ultrasound Guided Cannulation The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Cannulation n=4 Participants The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.	Ultrasound Guided Cannulation n=5 Participants The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device	Total n=9 Participants Total of all reporting groups
Age, Continuous	52.5 years n=93 Participants	66 years n=4 Participants	61.5 years n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 weeks from use of fistula

Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.

Outcome measures

Outcome measures
Measure	Standard Cannulation n=4 Participants The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.	Ultrasound Guided Cannulation n=5 Participants The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device
Infiltration Due to Dialysis Access Cannulation	5 infiltration events	7 infiltration events

SECONDARY outcome

Timeframe: 3 weeks from use of fistula

Measured using a scale of 1-10 with 10 being the most severe pain

Outcome measures

Outcome measures
Measure	Standard Cannulation n=4 Participants The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.	Ultrasound Guided Cannulation n=5 Participants The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device
Patient Pain Scale	2.1 score on a scale Standard Deviation 2.0	2.6 score on a scale Standard Deviation 1.8

Adverse Events

Standard Cannulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound Guided Cannulation

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. Lalathaksha Kumbar

Henry Ford Hospital

Phone: 3136271761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place