Ventilator Associated EventsNCT03850340
Evaluation of the Review of Automated Ventilator Data's Effect on the Incidence of Ventilator Associated Events in a Medical Surgical Intensive Care Unit
An observational study of Ventilator Associated Events, run by St. Joseph's/Candler Health System.
Trial summary
This study will be a retrospective, observational analysis study of ventilator patients in the Medical Surgical Intensive Care unit being monitored via automated near real-time ventilator analytical software. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Events
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2019to 31 Dec 2019
- 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: includes all mechanically ventilated patients in the study center's Medical-Surgical Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.
Who may be able to join
- includes all mechanically ventilated patients in the Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.
Who cannot join
- any patients under the age of 18 or mechanically ventilated for < 3days.
About this study
Official title: Retrospective Evaluation of the Review of Automated Ventilator Data's Effect on the Incidence of Ventilator Associated Events in a Medical Surgical Intensive Care Unit
This study will be a retrospective, observational analysis study of ventilator patients in the Medical Surgical Intensive Care unit being monitored via automated near real-time ventilator analytical software.
Read the detailed description
This study will be a retrospective review of data via chart review of all mechanically ventilated patients in an Intensive Care unit meeting our inclusion criteria during the pre-implementation and post-implementation phases of the study. Data will be collected and a detailed analysis of outcomes will be performed. The major parameters that will be measured will focus on the rate of ventilator associated events during each phases of the analysis.
Ventilator associated events will be defined as Ventilator associated Conditions (VACs), Infection related Ventilator Associated Conditions (IVACs) and Probable Ventilator Associated Pneumonias (PVAPs). According to the Center for Disease \& Control a VAC occurs after a patients has ≥ 2 days of stable or decreasing minimum FiO2 or PEEP values and then experiences at least one of the following: increased in the daily minimum FiO2 of ≥ 0.20 over the daily minimum FiO2 in the baseline period, sustained for ≥ 2 calendar days or increase in the daily minimum PEEP values of ≥ 3 cmH2O over the daily minimum PEEP in the baseline period sustained for ≥ 2 calendar days. An IVAC is defined as the occurrence on or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, the patient meets both of the following criteria: 1) Temperature > 38C, or white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 and a new antimicrobial agents(s) is started for ≥ 4 calendar days. A PVAP is occurs when a patient meets the criteria for a VAC and IVAC and one of the following criteria are met: 1) Purulent respiratory secretions (from one or more specimen collections). 2) Positive culture (qualitative, semi-quantitative) of sputum, endotracheal aspirate, bronchoalveolar lavage, lung tissue, or protected specimen brushing.
- Conditions
- Ventilator Associated Events
- Keywords
- Ventilator Associated Conditions, Infection Related Ventilator Associated Conditions, Probable Ventilator Associated Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilator Associated Events
Measure of the number of occurrences of ventilator associated events
Measured: 03/01/2014 until 02/28/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start31 Mar 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated EventsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's/Candler Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harold Julius-Augustus Oglesby, St. Joseph's/Candler Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850340
- Sponsor's protocol ID
- IRB# 18-027
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Review of Automated Ventilator Data's Effect on the Incidence of Ventilator Associated Events in a Medical Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03850340
- Acronym / sponsor ID
- IRB# 18-027
- Conditions
- Ventilator Associated Events
- Keywords
- Ventilator Associated Conditions, Infection Related Ventilator Associated Conditions, Probable Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Joseph's/Candler Health SystemUniversity, hospital or other
- Study start
- 31 Mar 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Feb 2019 (actual)
- 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.
This study will be a retrospective, observational analysis study of ventilator patients in the Medical Surgical Intensive Care unit being monitored via automated near real-time ventilator analytical software.
Detailed description
This study will be a retrospective review of data via chart review of all mechanically ventilated patients in an Intensive Care unit meeting our inclusion criteria during the pre-implementation and post-implementation phases of the study. Data will be collected and a detailed analysis of outcomes will be performed. The major parameters that will be measured will focus on the rate of ventilator associated events during each phases of the analysis.
Ventilator associated events will be defined as Ventilator associated Conditions (VACs), Infection related Ventilator Associated Conditions (IVACs) and Probable Ventilator Associated Pneumonias (PVAPs). According to the Center for Disease \& Control a VAC occurs after a patients has ≥ 2 days of stable or decreasing minimum FiO2 or PEEP values and then experiences at least one of the following: increased in the daily minimum FiO2 of ≥ 0.20 over the daily minimum FiO2 in the baseline period, sustained for ≥ 2 calendar days or increase in the daily minimum PEEP values of ≥ 3 cmH2O over the daily minimum PEEP in the baseline period sustained for ≥ 2 calendar days. An IVAC is defined as the occurrence on or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, the patient meets both of the following criteria: 1) Temperature > 38C, or white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 and a new antimicrobial agents(s) is started for ≥ 4 calendar days. A PVAP is occurs when a patient meets the criteria for a VAC and IVAC and one of the following criteria are met: 1) Purulent respiratory secretions (from one or more specimen collections). 2) Positive culture (qualitative, semi-quantitative) of sputum, endotracheal aspirate, bronchoalveolar lavage, lung tissue, or protected specimen brushing.
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
- includes all mechanically ventilated patients in the study center's Medical-Surgical Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.
Key inclusion criteria (1 listed)
- includes all mechanically ventilated patients in the Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.
Key exclusion criteria (1 listed)
- any patients under the age of 18 or mechanically ventilated for < 3days.
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
Incidence of Ventilator Associated Events
Time frame: 03/01/2014 until 02/28/2019
Measure of the number of occurrences of ventilator associated events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
Related trials for Ventilator Associated Events
Not yet recruiting
Effectiveness of an Evidence-Based Respiratory and Renal Care Training With Case-Based Discussion on Nurses' Clinical Reasoning, Knowledge & Practice, Nurse-Physician Collaboration and Mechanically Ventilated Patient Outcomes in a Tertiary-Level ICU in Bangladesh
Ventilator-Associated Events, Acute Kidney Injury
Active, not recruiting
Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.
Ventilation, ARDS
Not yet recruiting
Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh
Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI)
Not yet recruiting
Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients
Ventilator Associated Events, Asynchrony, Patient-Ventilator
Active, not recruitingObservational study
Evaluating the Clinical Utility of Modified Ventilator-Associated Event Criteria in Predicting ICU Mortality and Ventilator Duration: Can Less Restrictive Definitions Improve Prediction?
Ventilator-Associated Events
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Events, run by St. Joseph's/Candler Health System.
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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. 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?
Results are not available in the source record.
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?
Incidence of Ventilator Associated Events (time frame: 03/01/2014 until 02/28/2019). 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 21 Feb 2019.