Analgesia-Based Sedation During Mechanical Ventilation
Clinical and Economical Impact of an Analgesia-Based, Goal-Directed, Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation. A Multicenter Study
Hypothesis: A protocolized algorithm for sedation in critically ill patients on mechanical ventilation can decrease ventilator days, costs and improve outcome.
This is a multicenter observational-interventional study on critically ill patients who require mechanical ventilation for more than 48 hours, involving 13 ICU in Chile. There are two periods (groups): a descriptive phase of sedation practices, and an interventional period in which an analgesia-based, goal-directed, nurse-driven sedation is applied.
Main outcome: ventilator-free days between both periods.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
This is a multicenter observational-interventional study on critically ill patients who require mechanical ventilation for more than 48 hours, involving 13 ICU in Chile.
Main exclusion criteria are neurologic impairment, previous chronic cardiac, liver and renal failure, second period of mechanical ventilation during hospitalization, short term expected mortality.
There is an initial descriptive phase of sedation practice, involving sedative drugs, sedation level assessment, and outcome: ventilator-free days, ICU stay, costs and mortality.
After a period of analysis and training, an analgesia-based, goal-directed, nurse-driven sedation protocol is applied. Fentanyl infusion is started and titrated to obtain a patient calm and cooperative or mildly sedated while on mechanical ventilation. Hypnotics and opiates i.v. boluses are allowed during the first hours of mechanical ventilation. Midazolam infusion is started if ventilatory distress continue despite fentanyl 1.8 µg/kg/min. Haldol, muscle relaxants and other sedative drugs are allowed depending on patient condition. After 48 hours of mechanical ventilation, sedative drugs are discontinued in the morning.
Main outcome: ventilator-free days. Secondary outcome: ICU stay, costs, and sedation quality. At 6 moths SF-36. Each period is planned to included at least 140 patients, for a 20% difference in ventilator-free days, with 80% power and a 0.05 type I error.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Coquimbo, Chile
- Rekruttering
- Hospital Regional de Coquimbo
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Kontakt:
- Hector Ugarte
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Santiago, Chile, 6510260
- Rekruttering
- Hospital Universidad Catolica de Chile
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Kontakt:
- Guillermo Bugedo
- Telefonnummer: 2 275 1992
- E-mail: bugedo@med.puc.cl
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Kontakt:
- Eduardo Tobar
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Santiago, Chile
- Rekruttering
- Clinica Alemana
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Kontakt:
- Vinko Tomicic
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Santiago, Chile
- Rekruttering
- Hospital Clinico Universidad de Chile
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Kontakt:
- Jose Castro
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Santiago, Chile
- Rekruttering
- Hospital Dipreca
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Kontakt:
- Jose Castro
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Santiago, Chile
- Rekruttering
- Hospital Luis Tisne
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Kontakt:
- Pilar Lora
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Santiago, Chile
- Rekruttering
- Hospital Militar
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Kontakt:
- Antonio Hernandez
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Santiago, Chile
- Aktiv, ikke rekrutterende
- Hospital Padre Hurtado
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Santiago, Chile
- Aktiv, ikke rekrutterende
- Hospital San Jose
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Santiago, Chile
- Rekruttering
- Hospital San Juan de Dios
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Kontakt:
- Hugo Gonzalez
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Santiago, Chile
- Rekruttering
- Hospital Sotero Del Rio
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Kontakt:
- Jorge Godoy
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Talca, Chile
- Rekruttering
- Hospital Regional de Talca
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Kontakt:
- Juan Jara
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Valparaiso, Chile
- Rekruttering
- Hospital Carlos Van Buren
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Kontakt:
- Eduardo Encalada
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Viña del Mar, Chile
- Ikke rekrutterer endnu
- Hospital Naval
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Kontakt:
- Eduardo Labarca
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients who require mechanical ventilation for more than 48 hours
Exclusion Criteria:
- Nervous system diseases
- Previous liver or renal failure
- Second episode of MV during same hospitalization
- Expected MV shorter than 48 hours
- Short term expected mortality.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Ventilator-free days
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Sekundære resultatmål
Resultatmål |
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Livskvalitet
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ICU stay
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ICU cost
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Sedation quality
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Guillermo Bugedo, MD, Universidad Católica de Chile
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
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
- SA05I20091
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