Trial Outcomes & Findings for Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED (NCT NCT02769442)

Results Overview

1. First attempt success, defined as one skin puncture (redirection permitted) which allows for completion of a blood draw and/or flush without extravasation. 2. Gauge size 3. Patient prior history of difficult IV access 4. Operator type (ED Technician/Registered Nurse/Physician Assistant/Nurse Practitioner/Resident/Attending) 5. Operator years of experience with IV access 6. Type of catheter used

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

600 participants

Primary outcome timeframe

Within first minute of IV access

Results posted on

2019-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Terumo SurFlash Plus Catheter Patients randomized to the Terumo catheter	Becton Dickinson (BD) Insyte Autoguard Catheter Patients randomized to the Becton Dickinson (BD) catheter
Overall Study STARTED	309	291
Overall Study COMPLETED	309	291
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Terumo SurFlash Plus Catheter n=309 Participants Patients randomized to the Terumo catheter	BD Insyte Autoguard Catheter n=291 Participants Patients randomized to the BD catheter	Total n=600 Participants Total of all reporting groups
Age, Customized Patient Age Mean	51.1 years STANDARD_DEVIATION 17.7 • n=309 Participants	50.9 years STANDARD_DEVIATION 17.7 • n=291 Participants	51 years STANDARD_DEVIATION 17.7 • n=600 Participants
Sex: Female, Male Female	201 Participants n=309 Participants	175 Participants n=291 Participants	376 Participants n=600 Participants
Sex: Female, Male Male	108 Participants n=309 Participants	116 Participants n=291 Participants	224 Participants n=600 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Within first minute of IV access

1. First attempt success, defined as one skin puncture (redirection permitted) which allows for completion of a blood draw and/or flush without extravasation. 2. Gauge size 3. Patient prior history of difficult IV access 4. Operator type (ED Technician/Registered Nurse/Physician Assistant/Nurse Practitioner/Resident/Attending) 5. Operator years of experience with IV access 6. Type of catheter used

Outcome measures

Outcome measures
Measure	Terumo SurFlash Plus Catheter n=309 Participants Patients randomized to the Terumo catheter	BD Insyte Autoguard Catheter n=291 Participants Patients randomized to the BD catheter
Number of Participants With First-skin Puncture Success	244 Participants	229 Participants

SECONDARY outcome

Timeframe: Within first minute of IV access

Compare the frequency of bleeding near the insertion site

Outcome measures

Outcome measures
Measure	Terumo SurFlash Plus Catheter n=309 Participants Patients randomized to the Terumo catheter	BD Insyte Autoguard Catheter n=291 Participants Patients randomized to the BD catheter
Number of Participants With Blood Visible at Site of Insertion	8 participants	92 participants

Adverse Events

Terumo SurFlash Plus Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BD Insyte Autoguard Catheter

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

Siamak Moayedi Md

University of Maryland School of Medicine, Department of Emergency Medicine

Phone: 4103288025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place