Trial Outcomes & Findings for The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates (NCT NCT02389725)

Results Overview

Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

121 participants

Primary outcome timeframe

baseline

Results posted on

2019-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Disposable Elastic Tourniquet disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.	Manual Blood Pressure Cuff manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Overall Study STARTED	59	60
Overall Study COMPLETED	59	60
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	Disposable Elastic Tourniquet n=59 Participants disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.	Manual Blood Pressure Cuff n=60 Participants manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)	Total n=119 Participants Total of all reporting groups
Age, Continuous	67 years n=59 Participants	62 years n=60 Participants	65 years n=119 Participants
Sex: Female, Male Female	33 Participants n=59 Participants	35 Participants n=60 Participants	68 Participants n=119 Participants
Sex: Female, Male Male	26 Participants n=59 Participants	25 Participants n=60 Participants	51 Participants n=119 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	59 Participants n=59 Participants	60 Participants n=60 Participants	119 Participants n=119 Participants

PRIMARY outcome

Timeframe: baseline

Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.

Outcome measures

Outcome measures
Measure	Disposable Elastic Tourniquet n=59 Participants disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.	Manual Blood Pressure Cuff n=60 Participants manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Peripheral IV Access Success Rate	42 Participants	43 Participants

SECONDARY outcome

Timeframe: baseline

The total number of peripheral IV access attempts for each subject., up to a maximum of four attempts. An attempt is defined as a needle penetrating the subject's skin surface.

Outcome measures

Outcome measures
Measure	Disposable Elastic Tourniquet n=59 Participants disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.	Manual Blood Pressure Cuff n=60 Participants manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Total Number of Peripheral IV Access Attempts One attempt	42 Participants	43 Participants
Total Number of Peripheral IV Access Attempts Two attempts	13 Participants	9 Participants
Total Number of Peripheral IV Access Attempts Three attempts	3 Participants	6 Participants
Total Number of Peripheral IV Access Attempts Four attempts	1 Participants	2 Participants

SECONDARY outcome

Timeframe: baseline

Total number of individual medical providers that attempt to access IV for each subject. An attempt is defined as a needle penetrating the surface of the subject's skin. Access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.

Outcome measures

Outcome measures
Measure	Disposable Elastic Tourniquet n=59 Participants disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.	Manual Blood Pressure Cuff n=60 Participants manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Total Number of Distinct Providers That Attempted IV Access One provider	51 Participants	50 Participants
Total Number of Distinct Providers That Attempted IV Access Two providers	7 Participants	10 Participants
Total Number of Distinct Providers That Attempted IV Access Three providers	1 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline

The number of subjects requiring one or more rescue techniques to access peripheral IV. These techniques include ultrasound guided peripheral IV access, central venous access, venous cut-down, interosseous access, and/or change in treatment plan due to unsuccessful access.

Outcome measures

Outcome measures
Measure	Disposable Elastic Tourniquet n=59 Participants disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.	Manual Blood Pressure Cuff n=60 Participants manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Rate of Rescue Techniques Used	6 Participants	3 Participants

Adverse Events

Disposable Elastic Tourniquet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Manual Blood Pressure Cuff

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. Tobias Kummer

Mayo Clinic

Phone: 507-255-4399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place