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Analgesia-Based Sedation During Mechanical Ventilation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT00403208
First received: November 22, 2006
Last updated: November 24, 2006
Last verified: November 2006
  Purpose

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
Ventilation, Mechanical
Respiratory Insufficiency
Critical Illness
Procedure: Analgesia based sedation in ICU patients

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical and Economical Impact of an Analgesia-Based, Goal-Directed, Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation. A Multicenter Study

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Ventilator-free days

Secondary Outcome Measures:
  • ICU stay
  • ICU cost
  • Sedation quality
  • Quality of life

Estimated Enrollment: 280
Study Start Date: March 2006
Estimated Study Completion Date: November 2006
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403208

Locations
Chile
Hospital Regional de Coquimbo
Coquimbo, Chile
Hospital Universidad Catolica de Chile
Santiago, Chile, 6510260
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 Regional de Talca
Talca, Chile
Hospital Carlos Van Buren
Valparaiso, Chile
Hospital Naval
Viña del Mar, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Guillermo Bugedo, MD Universidad Catolica de Chile
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00403208     History of Changes
Other Study ID Numbers: SA05I20091 
Study First Received: November 22, 2006
Last Updated: November 24, 2006
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Pontificia Universidad Catolica de Chile:
Ventilation, Mechanical
Sedation

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 06, 2016