Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403208
Status:
UNKNOWN
Last Update Posted:
2006-11-28
First Post:
2006-11-22
Brief Title:
Analgesia-Based Sedation During Mechanical Ventilation
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Clinical and Economical Impact of an Analgesia-Based Goal-Directed Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation A Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 iv boluses are allowed during the first hours of mechanical ventilation Midazolam infusion is started if ventilatory distress continue despite fentanyl 18 µgkgmin 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 005 type I error
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 iv boluses are allowed during the first hours of mechanical ventilation Midazolam infusion is started if ventilatory distress continue despite fentanyl 18 µgkgmin 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 005 type I error
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None