- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01426217
Reduction in IV Associated Contamination
20. september 2018 opdateret af: Dartmouth-Hitchcock Medical Center
Reduction in Intraoperative Lumen Contamination of Standard 3-Way Open Lumen Stopcock Sets Through Use of a Novel, Passive Bundle
The purpose of this study is to investigate whether implementing a novel syringe and IV stopcock cap system impregnated with alcohol will reduce IV catheter bacterial contamination and infections in patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Bacterial contamination of patient intravenous stopcock sets is a common intraoperative event associated with increased patient mortality, possibly via an infectious mechanism.
The most common type of intravenous tubing used in operating rooms is the open lumen stopcock set which lacks a barrier between the environment and intraluminal space, and thus the intravascular space of the patient.
The stopcock connector can be easily contaminated by provider hands due to improper handling of the device and/or contaminated by soiled syringe tips subsequently connected to the device.
Further, the stopcock connector is often left uncapped by the provider and directly exposed to the environment.
Thus, common breaches in intraoperative aseptic practice of healthcare providers can lead to bacterial contamination of the endoluminal space of the open lumen device.
The primary aim of the current study is to assess the efficacy of a passive bundle designed to decrease intravenous stopcock and tubing intraluminal bacterial contamination.
This passive bundle includes two novel interventions, a DOCit station and HubScrub caps.
The HubScrub is designed to clean the needleless connectors and open lumen stopcock systems.
The DOCit station is designed to simultaneously clean the interior and exterior of needle-less luer connectors of syringes with isopropyl alcohol while also providing a method of storage and organization of multiple syringes.
The investigators hypothesize that the application of this passive bundle to the standard open lumen system commonly employed by anesthesia providers in the operating room will significantly reduce bacterial contamination of standard 3-way open lumen stopcock sets and improve patient safety.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
594
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult patient undergoing surgery or procedure in operating room
- Undergoing general anesthesia
Exclusion Criteria:
- Children (age < 18 years)
- Lack of intravenous access
- failure of anesthesia provider to complete training on experimental device
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
Control arm using standard of care operating room procedures and equipment
|
|
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Eksperimentel: Problem Solving Innovations (PSI) Experimental
Implementation of the passive bundle including HubScrub and DocIt
|
Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of Bacterial IV Stopcock Lumen Contamination
Tidsramme: 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
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48 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination
Tidsramme: Until positive, up to 5 days
|
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.
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Until positive, up to 5 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bryan S Brindeiro, MD, Dartmouth-Hitchcock Medical Center
- Studieleder: Randy W Loftus, MD, Dartmouth-Hitchcock Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.
- Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.
- Loftus RW, Muffly MK, Brown JR, Beach ML, Koff MD, Corwin HL, Surgenor SD, Kirkland KB, Yeager MP. Hand contamination of anesthesia providers is an important risk factor for intraoperative bacterial transmission. Anesth Analg. 2011 Jan;112(1):98-105. doi: 10.1213/ANE.0b013e3181e7ce18. Epub 2010 Aug 4.
- Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a passive catheter care system. Anesth Analg. 2012 Dec;115(6):1315-23. doi: 10.1213/ANE.0b013e31826d2aa4. Epub 2012 Nov 9.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. november 2011
Studieafslutning (Faktiske)
1. november 2011
Datoer for studieregistrering
Først indsendt
29. august 2011
Først indsendt, der opfyldte QC-kriterier
30. august 2011
Først opslået (Skøn)
31. august 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 22743
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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