Trial Outcomes & Findings for Reduction in IV Associated Contamination (NCT NCT01426217)

Results Overview

The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

594 participants

Primary outcome timeframe

48 hours

Results posted on

2018-10-18

Participant Flow

The study was conducted over 3-month period (Aug 1, 2011 to Nov 8, 2011) at Dartmouth-Hitchcock Medical Center, a tertiary care and level 1 trauma center in New Hampshire with 400 inpatient beds and 28 operating suites. The operating rooms enrolled during the study period were randomly selected on a daily basis from the available 28 operating rooms

Participant milestones

Participant milestones
Measure	Control Control arm using standard of care operating room procedures and equipment.	Experimental Group Implementation of passive bundle which includes HubScrub and DOCIt device into the operating room environment.
Overall Study STARTED	314	280
Overall Study COMPLETED	306	266
Overall Study NOT COMPLETED	8	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Control arm using standard of care operating room procedures and equipment.	Experimental Group Implementation of passive bundle which includes HubScrub and DOCIt device into the operating room environment.
Overall Study lost sample	8	14

Baseline Characteristics

Reduction in IV Associated Contamination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=306 Participants Control arm using standard of care operating room procedures and equipment	Experimental Group n=266 Participants Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.	Total n=572 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 16.3 • n=5 Participants	57.5 years STANDARD_DEVIATION 15.7 • n=7 Participants	57.6 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	142 Participants n=7 Participants	304 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants	124 Participants n=7 Participants	268 Participants n=5 Participants
Region of Enrollment United States	306 participants n=5 Participants	266 participants n=7 Participants	572 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed

Outcome measures

Outcome measures
Measure	Control n=306 Operating Rooms Control arm using standard of care operating room procedures and equipment	PSI Experimental n=266 Operating Rooms Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment. Problem Solving Innovations (PSI) Passive Bundle: PSI Medical HubScrub, PSI Medical DocIt
Presence of Bacterial IV Stopcock Lumen Contamination	41 percent stopcock contamination rate	32 percent stopcock contamination rate

SECONDARY outcome

Timeframe: Until positive, up to 5 days

Population: Specific data for each arm can not be obtained. Sincere efforts were made to obtain and report the data, however, no data is available.

Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism.

Outcome measures

Outcome measures
Measure	Control n=572 Participants Control arm using standard of care operating room procedures and equipment	PSI Experimental Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment. Problem Solving Innovations (PSI) Passive Bundle: PSI Medical HubScrub, PSI Medical DocIt
Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination	86 cases of effluent contamination	—

Adverse Events

Entire Population

Serious events: 0 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Entire Population n=572 participants at risk Experimental and Control groups were combined for analysis. Control arm used standard of care operating room procedures and equipment. Experimental arm implemented a of passive bundle which includes HubScrub and DocIt device into the operating room environment.
Infections and infestations HCAI	12.2% 70/572 • 30 days Experimental \& Control groups were combined for analysis. Sincere efforts were made to gather \& report data, however, no specific data for each group is available. Events: * Presence of elevated white blood cells count, fever, anti-infection meds order, office visit/inpatient progress note noting signs of infection \&/or bacterial cultures; Positive for ≥1 evaluated if HealthCare Associated Infection * Clinical diagnosis of IV catheter-associated phlebitis
Vascular disorders Phlebitis	3.3% 19/572 • 30 days Experimental \& Control groups were combined for analysis. Sincere efforts were made to gather \& report data, however, no specific data for each group is available. Events: * Presence of elevated white blood cells count, fever, anti-infection meds order, office visit/inpatient progress note noting signs of infection \&/or bacterial cultures; Positive for ≥1 evaluated if HealthCare Associated Infection * Clinical diagnosis of IV catheter-associated phlebitis

Additional Information

Randy Loftus, MD

Dartmouth-Hitchcock Medical Center

Phone: (603) 650-6177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place