Clinical trial NCT00403208: Analgesia-Based Sedation During Mechanical Ventilation
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilation, Mechanical
Respiratory Insufficiency
Critical Illness
Keywords: Ventilation, Mechanical
Sedation
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2006-11-23
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ventilator-free days
Secondary outcomes:
measure: ICU stay
measure: ICU cost
measure: Sedation quality
measure: Quality of life
Other outcomes:
Locations:
city: Coquimbo
country: Chile
facility: Hospital Regional de Coquimbo
city: Santiago
country: Chile
facility: Hospital Universidad Catolica de Chile
city: Santiago
country: Chile
facility: Clinica Alemana
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
city: Santiago
country: Chile
facility: Hospital Dipreca
city: Santiago
country: Chile
facility: Hospital Luis Tisne
city: Santiago
country: Chile
facility: Hospital Militar
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Santiago
country: Chile
facility: Hospital San Jose
city: Santiago
country: Chile
facility: Hospital San Juan de Dios
city: Santiago
country: Chile
facility: Hospital Sotero del Rio
city: Talca
country: Chile
facility: Hospital Regional de Talca
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
city: Viña del Mar
country: Chile
facility: Hospital Naval
Study officials:
affiliation: Universidad Catolica de Chile
name: Guillermo Bugedo, MD
role: PRINCIPAL_INVESTIGATOR
References: