Analgesia-Based Sedation During Mechanical Ventilation
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|ClinicalTrials.gov Identifier: NCT00403208|
Recruitment Status : Unknown
Verified November 2006 by Pontificia Universidad Catolica de Chile.
Recruitment status was: Recruiting
First Posted : November 23, 2006
Last Update Posted : November 28, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventilation, Mechanical Respiratory Insufficiency Critical Illness||Procedure: Analgesia based sedation in ICU patients||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||280 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical and Economical Impact of an Analgesia-Based, Goal-Directed, Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation. A Multicenter Study|
|Study Start Date :||March 2006|
|Study Completion Date :||November 2006|
- Ventilator-free days
- ICU stay
- ICU cost
- Sedation quality
- Quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403208
|Contact: Guillermo Bugedo, MD||562 firstname.lastname@example.org|
|Contact: Eduardo Tobar||562 email@example.com|
|Hospital Regional de Coquimbo||Recruiting|
|Contact: Hector Ugarte|
|Hospital Universidad Catolica de Chile||Recruiting|
|Santiago, Chile, 6510260|
|Contact: Guillermo Bugedo 2 275 1992 firstname.lastname@example.org|
|Contact: Eduardo Tobar|
|Contact: Vinko Tomicic|
|Hospital Clinico Universidad de Chile||Recruiting|
|Contact: Jose Castro|
|Contact: Jose Castro|
|Hospital Luis Tisne||Recruiting|
|Contact: Pilar Lora|
|Contact: Antonio Hernandez|
|Hospital Padre Hurtado||Active, not recruiting|
|Hospital San Jose||Active, not recruiting|
|Hospital San Juan de Dios||Recruiting|
|Contact: Hugo Gonzalez|
|Hospital Sotero del Rio||Recruiting|
|Contact: Jorge Godoy|
|Hospital Regional de Talca||Recruiting|
|Contact: Juan Jara|
|Hospital Carlos Van Buren||Recruiting|
|Contact: Eduardo Encalada|
|Hospital Naval||Not yet recruiting|
|Viña del Mar, Chile|
|Contact: Eduardo Labarca|
|Principal Investigator:||Guillermo Bugedo, MD||Universidad Catolica de Chile|