Analgesia-Based Sedation During Mechanical Ventilation

November 24, 2006 updated by: Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Coquimbo, Chile
        • Recruiting
        • Hospital Regional de Coquimbo
        • Contact:
          • Hector Ugarte
      • Santiago, Chile, 6510260
        • Recruiting
        • Hospital Universidad Catolica de Chile
        • Contact:
        • Contact:
          • Eduardo Tobar
      • Santiago, Chile
        • Recruiting
        • Clinica Alemana
        • Contact:
          • Vinko Tomicic
      • Santiago, Chile
        • Recruiting
        • Hospital Clínico Universidad de Chile
        • Contact:
          • Jose Castro
      • Santiago, Chile
        • Recruiting
        • Hospital Dipreca
        • Contact:
          • Jose Castro
      • Santiago, Chile
        • Recruiting
        • Hospital Luis Tisne
        • Contact:
          • Pilar Lora
      • Santiago, Chile
        • Recruiting
        • Hospital Militar
        • Contact:
          • Antonio Hernandez
      • Santiago, Chile
        • Active, not recruiting
        • Hospital Padre Hurtado
      • Santiago, Chile
        • Active, not recruiting
        • Hospital San José
      • Santiago, Chile
        • Recruiting
        • Hospital San Juan de Dios
        • Contact:
          • Hugo Gonzalez
      • Santiago, Chile
        • Recruiting
        • Hospital Sótero del Río
        • Contact:
          • Jorge Godoy
      • Talca, Chile
        • Recruiting
        • Hospital Regional de Talca
        • Contact:
          • Juan Jara
      • Valparaiso, Chile
        • Recruiting
        • Hospital Carlos Van Buren
        • Contact:
          • Eduardo Encalada
      • Viña del Mar, Chile
        • Not yet recruiting
        • Hospital Naval
        • Contact:
          • Eduardo Labarca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ventilator-free days

Secondary Outcome Measures

Outcome Measure
Quality of life
ICU stay
ICU cost
Sedation quality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Guillermo Bugedo, MD, Universidad Católica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2006

Last Update Submitted That Met QC Criteria

November 24, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA05I20091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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