NCT00403208

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

November 28, 2006

Status Verified

November 1, 2006

First QC Date

November 22, 2006

Last Update Submit

November 24, 2006

Conditions

Ventilation, MechanicalRespiratory InsufficiencyCritical Illness

Keywords

Ventilation, MechanicalSedation

Outcome Measures

Primary Outcomes (1)

  • Ventilator-free days

Secondary Outcomes (4)

  • ICU stay

  • ICU cost

  • Sedation quality

  • Quality of life

Interventions

Analgesia based sedation in ICU patientsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who require mechanical ventilation for more than 48 hours

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Regional de Coquimbo

Coquimbo, Chile

RECRUITING

Hospital Universidad Catolica de Chile

Santiago, 6510260, Chile

RECRUITING

Clinica Alemana

Santiago, Chile

RECRUITING

Hospital Clinico Universidad de Chile

Santiago, Chile

RECRUITING

Hospital Dipreca

Santiago, Chile

RECRUITING

Hospital Luis Tisne

Santiago, Chile

RECRUITING

Hospital Militar

Santiago, Chile

RECRUITING

Hospital Padre Hurtado

Santiago, Chile

ACTIVE NOT RECRUITING

Hospital San Jose

Santiago, Chile

ACTIVE NOT RECRUITING

Hospital San Juan de Dios

Santiago, Chile

RECRUITING

Hospital Sotero del Rio

Santiago, Chile

RECRUITING

Hospital Regional de Talca

Talca, Chile

RECRUITING

Hospital Carlos Van Buren

Valparaíso, Chile

RECRUITING

Hospital Naval

Viña del Mar, Chile

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory AspirationRespiratory InsufficiencyCritical Illness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Guillermo Bugedo, MD

    Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Bugedo, MD

CONTACT

562 3543972bugedo@med.puc.cl

Eduardo Tobar

CONTACT

562 3543972edotobar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

March 1, 2006

Study Completion

November 1, 2006

Last Updated

November 28, 2006

Record last verified: 2006-11

Locations

CL(14)