Ventilator-Associated Lung InjuryNCT02977676
Ventilator-Associated Events: Prevalence, Outcome and Preventability
An observational study of Ventilator-Associated Lung Injury, run by Hospital Sao Domingos.
Trial summary
The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Lung Injury
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jan 2016
- Phase
- Observational
- 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
Study population: Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.
Who may be able to join
- Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.
Who cannot join
- Patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 days.
About this study
The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. The preventability of VAE will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope VAE.
Read the detailed description
This is a retrospective analysis of prospectively collected data, approved by the Research Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.
Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days.
At admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure.
Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable followed definition criteria of the National Healthcare Safety Network / Center for Disease Control and Prevention.
The percentage of adherence to the bundle of preventive measures of VAE prevention was registered.
- Conditions
- Ventilator-Associated Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who developed ventilator-associated events
Measured: 1 year
All cause Mortality
Measured: 1 year
Secondary outcomes (2)
Duration of mechanical ventilation
Measured: 1 year
Percentage of adherence to the package of VAE preventive measures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startFeb 2013
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated Lung InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE R AZEVEDO, MA, PhD, Principal investigator, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977676
- Sponsor's protocol ID
- CONEP 1.449.854
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator-Associated Events: Prevalence, Outcome and Preventability
- ClinicalTrials.gov ID
- NCT02977676
- Acronym / sponsor ID
- CONEP 1.449.854
- Conditions
- Ventilator-Associated Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2016 (actual)
- First posted
- 30 Nov 2016 (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.
The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. The preventability of VAE will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope VAE.
Detailed description
This is a retrospective analysis of prospectively collected data, approved by the Research Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.
Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days.
At admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure.
Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable followed definition criteria of the National Healthcare Safety Network / Center for Disease Control and Prevention.
The percentage of adherence to the bundle of preventive measures of VAE prevention was registered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.
Key inclusion criteria (1 listed)
- Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.
Key exclusion criteria (1 listed)
- Patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who developed ventilator-associated events
Time frame: 1 year
All cause Mortality
Time frame: 1 year
2 secondary outcomes
Duration of mechanical ventilation
Time frame: 1 year
Percentage of adherence to the package of VAE preventive measures
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury
Ventilator-associated Pneumonia, Traumatic Brain Injury
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Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
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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.
JOSE R AZEVEDO, MA, PhD principal investigator
Hospital Sao Domingos
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Lung Injury, run by Hospital Sao Domingos.
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 1 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: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who developed ventilator-associated events (time frame: 1 year). The study lists 2 primary outcomes in all. 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 30 Nov 2016.