Analgesia-Based Sedation During Mechanical Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
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

Resource links provided by NLM:


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
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

Contacts
Contact: Guillermo Bugedo, MD 562 3543972 bugedo@med.puc.cl
Contact: Eduardo Tobar 562 3543972 edotobar@gmail.com

Locations
Chile
Hospital Regional de Coquimbo Recruiting
Coquimbo, Chile
Contact: Hector Ugarte         
Hospital Sotero del Rio Recruiting
Santiago, Chile
Contact: Jorge Godoy         
Hospital San Juan de Dios Recruiting
Santiago, Chile
Contact: Hugo Gonzalez         
Hospital Universidad Catolica de Chile Recruiting
Santiago, Chile, 6510260
Contact: Guillermo Bugedo    2 275 1992    bugedo@med.puc.cl   
Contact: Eduardo Tobar         
Hospital Dipreca Recruiting
Santiago, Chile
Contact: Jose Castro         
Hospital Clinico Universidad de Chile Recruiting
Santiago, Chile
Contact: Jose Castro         
Hospital Militar Recruiting
Santiago, Chile
Contact: Antonio Hernandez         
Clinica Alemana Recruiting
Santiago, Chile
Contact: Vinko Tomicic         
Hospital Padre Hurtado Active, not recruiting
Santiago, Chile
Hospital Luis Tisne Recruiting
Santiago, Chile
Contact: Pilar Lora         
Hospital San Jose Active, not recruiting
Santiago, Chile
Hospital Regional de Talca Recruiting
Talca, Chile
Contact: Juan Jara         
Hospital Carlos Van Buren Recruiting
Valparaiso, Chile
Contact: Eduardo Encalada         
Hospital Naval Not yet recruiting
Viña del Mar, Chile
Contact: Eduardo Labarca         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Guillermo Bugedo, MD Universidad Catolica de Chile
  More Information

Additional Information:
No publications provided

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
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014