Analgesia-Based Sedation During Mechanical Ventilation

Critical Illness Clinical Trial

Official title:

Clinical and Economical Impact of an Analgesia-Based, Goal-Directed, Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation. A Multicenter Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00403208
• Other study ID #: SA05I20091
• Status: Unknown status
• Phase: N/A
• First received: November 22, 2006
• Last updated: November 24, 2006
• Start date: March 2006
• Est. completion date: November 2006

Study information

• Verified date: November 2006
• Source: Pontificia Universidad Catolica de Chile
• Contact: Guillermo Bugedo, MD
• Phone: 562 3543972
• Email: bugedo[@]med.puc.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 280
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Ventilation, Mechanical

Intervention

Procedure:
• Analgesia based sedation in ICU patients

Locations

Country	Name	City	State
Chile	Hospital Regional de Coquimbo	Coquimbo
Chile	Clinica Alemana	Santiago
Chile	Hospital Clinico Universidad de Chile	Santiago
Chile	Hospital Dipreca	Santiago
Chile	Hospital Luis Tisne	Santiago
Chile	Hospital Militar	Santiago
Chile	Hospital Padre Hurtado	Santiago
Chile	Hospital San Jose	Santiago
Chile	Hospital San Juan de Dios	Santiago
Chile	Hospital Sotero del Rio	Santiago
Chile	Hospital Universidad Catolica de Chile	Santiago
Chile	Hospital Regional de Talca	Talca
Chile	Hospital Carlos Van Buren	Valparaiso
Chile	Hospital Naval	Viña del Mar

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free days
Secondary	ICU stay
Secondary	ICU cost
Secondary	Sedation quality
Secondary	Quality of life

External Links

•   The whole extended protocol is described (in spanish)