Ventilation, MechanicalNCT00403208
Analgesia-Based Sedation During Mechanical Ventilation
A study testing Analgesia based sedation in ICU patients in people with Ventilation, Mechanical and Respiratory Insufficiency, run by Pontificia Universidad Catolica de Chile at 14 sites in Chile.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation, Mechanical, Respiratory Insufficiency, Critical Illness
- What is being tested?
- Analgesia based sedation in ICU patients
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 14 sitesChile
- Study dates
- Mar 2006to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who require mechanical ventilation for more than 48 hours
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Chile14 sites, 12 recruiting
- Recruiting
Hospital Regional de Coquimbo
Coquimbo
Hector Ugarte
- Recruiting
Hospital Universidad Catolica de Chile
Santiago, 6510260
Guillermo Bugedo, 2 275 1992, bugedo@med.puc.cl
Eduardo Tobar
- Recruiting
Clinica Alemana
Santiago
Vinko Tomicic
- Recruiting
Hospital Clinico Universidad de Chile
Santiago
Jose Castro
- Recruiting
Hospital Dipreca
Santiago
Jose Castro
- Recruiting
Hospital Luis Tisne
Santiago
Pilar Lora
- Recruiting
Hospital Militar
Santiago
Antonio Hernandez
- Active, not recruiting
Hospital Padre Hurtado
Santiago
- Active, not recruiting
Hospital San Jose
Santiago
- Recruiting
Hospital San Juan de Dios
Santiago
Hugo Gonzalez
- Recruiting
Hospital Sotero del Rio
Santiago
Jorge Godoy
- Recruiting
Hospital Regional de Talca
Talca
Juan Jara
- Recruiting
Hospital Carlos Van Buren
Valparaíso
Eduardo Encalada
- Not yet recruiting
Hospital Naval
Viña del Mar
Eduardo Labarca
About this study
Official title: 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.
Read the 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.
- Being tested
- Analgesia based sedation in ICU patients
- Keywords
- Ventilation, Mechanical, Sedation
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia based sedation in ICU patientsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days
Secondary outcomes (4)
ICU stay
ICU cost
Sedation quality
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startMar 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Investigators
- Guillermo Bugedo, MD, Principal investigator, Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403208
- Sponsor's protocol ID
- SA05I20091
- Status last verified
- Nov 2006
- First submitted
- 22 Nov 2006
- Last updated
- 28 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economical Impact of an Analgesia-Based, Goal-Directed, Nurse-Driven Sedation Protocol on Patients on Mechanical Ventilation. A Multicenter Study
- ClinicalTrials.gov ID
- NCT00403208
- Acronym / sponsor ID
- SA05I20091
- Keywords
- Ventilation, Mechanical, Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Nov 2006
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who require mechanical ventilation for more than 48 hours
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesia based sedation in ICU patients | Procedure or surgery | – |
Primary outcome
Ventilator-free days
4 secondary outcomes
ICU stay
ICU cost
Sedation quality
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Bugedo, MD principal investigator
Universidad Catolica de Chile
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia based sedation in ICU patients in people with Ventilation, Mechanical and Respiratory Insufficiency, run by Pontificia Universidad Catolica de Chile at 14 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Bugedo, MD (562 3543972, bugedo@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2006.