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Sponsored by: |
Pontificia Universidad Catolica de Chile |
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Information provided by: | Pontificia Universidad Catolica de Chile |
ClinicalTrials.gov Identifier: | NCT00403208 |
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 | Intervention |
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Ventilation, Mechanical Respiratory Insufficiency Critical Illness |
Procedure: Analgesia based sedation in ICU patients |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical and Economical Impact of an Analgesia-Based, Goal-Directed, Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation. A Multicenter Study |
Estimated Enrollment: | 280 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guillermo Bugedo, MD | 562 3543972 | bugedo@med.puc.cl |
Contact: Eduardo Tobar | 562 3543972 | edotobar@gmail.com |
Chile | |
Hospital Sotero del Rio | Recruiting |
Santiago, Chile | |
Contact: Jorge Godoy | |
Hospital San Juan de Dios | Recruiting |
Santiago, Chile | |
Contact: Hugo Gonzalez | |
Hospital Militar | Recruiting |
Santiago, Chile | |
Contact: Antonio Hernandez | |
Hospital Dipreca | Recruiting |
Santiago, Chile | |
Contact: Jose Castro | |
Hospital Regional de Talca | Recruiting |
Talca, Chile | |
Contact: Juan Jara | |
Hospital Carlos Van Buren | Recruiting |
Valparaiso, Chile | |
Contact: Eduardo Encalada | |
Hospital Regional de Coquimbo | Recruiting |
Coquimbo, Chile | |
Contact: Hector Ugarte | |
Hospital Universidad Catolica de Chile | Recruiting |
Santiago, Chile, 6510260 | |
Contact: Guillermo Bugedo 2 275 1992 bugedo@med.puc.cl | |
Contact: Eduardo Tobar | |
Clinica Alemana | Recruiting |
Santiago, Chile | |
Contact: Vinko Tomicic | |
Hospital Padre Hurtado | Active, not recruiting |
Santiago, Chile | |
Hospital San Jose | Active, not recruiting |
Santiago, Chile | |
Hospital Naval | Not yet recruiting |
Viña del Mar, Chile | |
Contact: Eduardo Labarca | |
Hospital Luis Tisne | Recruiting |
Santiago, Chile | |
Contact: Pilar Lora | |
Hospital Clinico Universidad de Chile | Recruiting |
Santiago, Chile | |
Contact: Jose Castro |
Principal Investigator: | Guillermo Bugedo, MD | Universidad Catolica de Chile |
Study ID Numbers: | SA05I20091 |
Study First Received: | November 22, 2006 |
Last Updated: | November 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00403208 |
Health Authority: | Chile: Comisión Nacional de Investigación Científica y Tecnológica |
Ventilation, Mechanical Sedation |
Respiratory Insufficiency Respiratory Tract Diseases Critical Illness Respiration Disorders |
Disease Attributes Pathologic Processes |