- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01935388
Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients
Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients
Many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. Common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. Small reports suggest that this method does not pose an increased infectious risk and is associated with significant cost savings.
Common canister protocols offer a solution to the discordance between inhaler sizes and average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug for several days to weeks of daily use. However, the average length of stay for most inpatients is only several days. Therefore, most inpatients do not use all of the canister contents, an unused resource that is potentially wasted.
The common canister approach has not been previously described in mechanically ventilated patients (people requiring intensive care unit admission on breathing machines). This study aims to assess the safety of common canister utilization by assessment and comparison of infection rates in the study and control group.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Barnes-Jewish Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit
Exclusion Criteria:
- lung transplant
- neutropenic
- contact isolation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Common canister
Use of a single MDI (instead of assigning each patient an individual MDI) for multiple mechanically ventilated patients.
Inhalers will undergo a stringent cleaning protocol between administrations and storage.
|
Drug administration via a shared canister with a standardized cleaning protocol.
|
|
Ingen indgriben: Control
Each patient will be assigned an individual inhaler as per standard of care practice.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ventilator-associated pneumonia (VAP)
Tidsramme: 48 hours after intubation
|
Pneumonia that developed in association with mechanical ventilation
|
48 hours after intubation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Inhaler drug cost
Tidsramme: During period of mechanical ventilation, which varies depending on patient's severity of illness and reason for intubation; on average may range from 3-5 days.
|
Inhaler charges accrued during mechanical ventilation
|
During period of mechanical ventilation, which varies depending on patient's severity of illness and reason for intubation; on average may range from 3-5 days.
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BJH CCP
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Kliniske forsøg med Ventilator Associated Pneumonia
-
Assiut UniversityIkke rekrutterer endnuVAP - Ventilator Associated Pneumonia
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Ente Ospedaliero Cantonale, BellinzonaAfsluttet
-
Ain Shams UniversityAfsluttetVAP - Ventilator Associated PneumoniaEgypten
-
Erasmus Medical CenterChiesi Farmaceutici S.p.A.AfsluttetVentilator Associated Pneumonia (VAP)Spanien, Holland
-
Andrzej Frycz Modrzewski Krakow UniversityAfsluttetVAP - Ventilator Associated PneumoniaPolen
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University of CambridgeCambridge University Hospitals NHS Foundation TrustRekrutteringVentilator Associated Pneumonia (VAP)Det Forenede Kongerige
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University of MichiganNational Institutes of Health (NIH); National Center for Advancing Translational...AfsluttetVAP - Ventilator Associated PneumoniaForenede Stater
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Tanta UniversityAfsluttetMekanisk ventilation | Ventilator Associated Pneumonia (VAP)Egypten
-
ShionogiAfsluttetHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spanien, Forenede Stater, Belgien, Canada, Tjekkiet, Estland, Frankrig, Georgien, Tyskland, Ungarn, Japan, Letland, Filippinerne, Puerto Rico, Den Russiske Føderation, Serbien, Taiwan, Ukraine
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University Hospital, Clermont-FerrandAfsluttetKritisk pleje | Mekanisk ventilation | Tandbørstning | Ventilator Associated Pneumonia Prevention | MundplejeFrankrig
Kliniske forsøg med Common canister
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University of PennsylvaniaAshoka University; Jindal Global UniversityAfsluttetAngst | Depressive symptomer | LykkeIndien
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University of Illinois at ChicagoNational Institute on Minority Health and Health Disparities (NIMHD); Sinai...Ikke rekrutterer endnuDepression | Angst | Traumatisk stress
-
University of PennsylvaniaUniversity of BathIkke rekrutterer endnuDepression | Angst | Lykke
-
University of PennsylvaniaTrukket tilbageAngst | Depressive symptomer | Lykke
-
University of PennsylvaniaOhio State University; Indiana University; University of Missouri, St. LouisRekrutteringDepression | Angst | TrivselForenede Stater
-
Johns Hopkins Bloomberg School of Public HealthUnited States Agency for International Development (USAID)AfsluttetDepression | Post traumatisk stress syndromUkraine
-
University of PennsylvaniaNational and Kapodistrian University of Athens, Greece; University Mental...Trukket tilbageAngst | Depressive symptomer | LykkeForenede Stater, Grækenland
-
Indiana UniversityAfsluttet
-
University of PennsylvaniaRekrutteringAngst | Depressive symptomerForenede Stater
-
Sara FleszarIkke rekrutterer endnuOpførsel | Human Papilloma Virus | Hensigt