Trial Outcomes & Findings for Effectiveness Study of the BOA(R)-Constricting IV Band (NCT NCT01104103)

Results Overview

This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

467 participants

Primary outcome timeframe

five minutes (average)

Results posted on

2012-08-20

Participant Flow

We randomly assigned the 26 healthcare providers (16 paramedics, 10 nurses) to use either the BOA® Constricting Band or elastic tourniquets for all IV attempts during the study. Thirteen subjects were in each group. Those that were randomized to the BOA group received training in the use of the device according to the manufacturer's instructions.

Participant milestones

Participant milestones
Measure	BOA(R) Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult	Standard Care Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
Overall Study STARTED	243	224
Overall Study COMPLETED	243	224
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness Study of the BOA(R)-Constricting IV Band

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BOA(R) n=243 Participants Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult	Standard Care n=224 Participants Nurse or paramedic uses standard IV starting technique in the upper extremity of adults	Total n=467 Participants Total of all reporting groups
Age Categorical <=18 years	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Age Categorical Between 18 and 65 years	175 participants n=5 Participants	178 participants n=7 Participants	353 participants n=5 Participants
Age Categorical >=65 years	60 participants n=5 Participants	43 participants n=7 Participants	103 participants n=5 Participants
Age Continuous	50.17 years STANDARD_DEVIATION 19.54 • n=5 Participants	46.78 years STANDARD_DEVIATION 19.01 • n=7 Participants	48.53 years STANDARD_DEVIATION 19.34 • n=5 Participants
Gender Female	122 participants n=5 Participants	104 participants n=7 Participants	226 participants n=5 Participants
Gender Male	115 participants n=5 Participants	113 participants n=7 Participants	228 participants n=5 Participants
Region of Enrollment United States	243 participants n=5 Participants	224 participants n=7 Participants	467 participants n=5 Participants

PRIMARY outcome

Timeframe: five minutes (average)

This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.

Outcome measures

Outcome measures
Measure	BOA(R) n=243 Participants Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult	Standard Care n=224 Participants Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
Success	198 participants	214 participants

SECONDARY outcome

Timeframe: Five minutes (average)

This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.

Outcome measures

Outcome measures
Measure	BOA(R) n=243 Participants Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult	Standard Care n=224 Participants Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
First Stick Success	167 participants	186 participants

Adverse Events

BOA(R)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

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. Richard Bradley

The University of Texas Health Science Center at Houston

Phone: 713-500-7878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place