- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63110
- Barnes-Jewish Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit
Exclusion Criteria:
- lung transplant
- neutropenic
- contact isolation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: Control
Each patient will be assigned an individual inhaler as per standard of care practice.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ventilator-associated pneumonia (VAP)
Tidsram: 48 hours after intubation
|
Pneumonia that developed in association with mechanical ventilation
|
48 hours after intubation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Inhaler drug cost
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BJH CCP
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