Analgesia-Based Sedation During Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Ventilation, Mechanical Respiratory Insufficiency Critical Illness

Keywords

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Ventilation, Mechanical Sedation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Analgesia based sedation in ICU patients

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Guillermo Bugedo, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Catolica de Chile

Reach out to these primary contacts for questions about participation or study logistics.

Guillermo Bugedo, MD

Role: CONTACT

Phone: 562 3543972

Email: [email protected]

Eduardo Tobar

Role: CONTACT

Phone: 562 3543972

Identifier Type: -

Identifier Source: org_study_id

Analgesia-Based Sedation During Mechanical Ventilation

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Analgesia based sedation in ICU patients

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pontificia Universidad Catolica de Chile

Principal Investigators

Guillermo Bugedo, MD

Locations

Hospital Regional de Coquimbo

Hospital Universidad Catolica de Chile

Clinica Alemana

Hospital Clinico Universidad de Chile

Hospital Dipreca

Hospital Luis Tisne

Hospital Militar

Hospital Padre Hurtado

Hospital San Jose

Hospital San Juan de Dios

Hospital Sotero del Rio

Hospital Regional de Talca

Hospital Carlos Van Buren

Hospital Naval

Countries

Central Contacts

Guillermo Bugedo, MD

Eduardo Tobar

Facility Contacts

Hector Ugarte

Guillermo Bugedo

Eduardo Tobar

Vinko Tomicic

Jose Castro

Jose Castro

Pilar Lora

Antonio Hernandez

Hugo Gonzalez

Jorge Godoy

Juan Jara

Eduardo Encalada

Eduardo Labarca

Other Identifiers

SA05I20091