- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111303
Mechanical Ventilation Parameters in HAP Patients
October 24, 2017 updated by: Radovan Uvizl, University Hospital Olomouc
Nosocomial Pneumonia as a Factor Influencing Parameters of Mechanical Ventilation: Results of a Retrospective, Observational Study
Hospital-acquired pneumonia (HAP) in patients in intensive care often requires the mechanical ventilation (MV).
Management and weaning from MV are given by specificity of this type of pulmonary inflammation.
Enrolled in the retrospective, observational study were all patients older than 18 years staying at the ICU of University Hospital in Olomouc, between 1 January 2011 and 31 December 2016.
The determination of the parameters of the MV, ICU length of stay, hospital length of stay and mortality in HAP group were compared with the control group of patients without HAP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hospital-acquired pneumonia (HAP) development influences the parameters of mechanical ventilation, intensive care unit (ICU) length of stay, hospital length of stay, need of tracheostomy, bronchoscopy, reconnection to MV and mortality.
We respect HAP definition: acute inflammation of the respiratory bronchioles, alveolar structures and pulmonary interstitium.
Clinically it is defined as the presence of newly developed or progressive infiltrates on chest radiographs plus at least two other signs of respiratory tract infection: temperature >38 °C, chest pain, purulent sputum, leukocytosis or leukopenia, signs of inflammation on auscultation, cough and/or respiratory insufficiency.
HAP is defined as pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission.
A retrospective, observational study processing data on all consecutive intensive care patients older than 18 years of age between 1 January 2011 and 31 December 2015.
The aim was to determine the incidence of potential risk factors and their impact on the development of HAP.
The primary outcome was investigation of the relationship between mechanical ventilation parameters and the presence of early- and late-onset HAP.
Enrolled in the study were patients staying at the ICU of the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, between 1 January 2011 and 31 December 2016.
The participants were all patients older than 18 years of age consecutively admitted to the ICU.
Study Type
Observational
Enrollment (Actual)
2654
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Enrolled in the study were patients staying at the ICU of the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, between 1 January 2011 and 31 December 2015.
The participants were all patients older than 18 years of age consecutively admitted to the ICU, who met HAP criteria.
Description
Inclusion Criteria:
- Age 18+
- Need of Mechanical ventilation (Pressure controlled mechanical ventilation or Pressure support ventilation)
Exclusion Criteria:
- Organ donor
- Need Volume controlled mechanical ventilation
- no mechanical ventilation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HAP patients
Mechanical ventilation, patients fulfilled HAP criteria
|
Connection to mechanical ventilator
|
non HAP patients
Mechanical ventilation, patients without HAP
|
Connection to mechanical ventilator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of mechanical ventilation
Time Frame: during MV
|
days of MV
|
during MV
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU length of stay
Time Frame: 1 month
|
length of stay in ICU
|
1 month
|
Hospital length of stay (LOS)
Time Frame: 1 month
|
length of hospital stay
|
1 month
|
Mortality
Time Frame: 1 month
|
mortality during Hospital LOS
|
1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inspiratory pressure
Time Frame: during MV
|
most high inspiratory pressure during MV
|
during MV
|
Positive end expiratory pressure (PEEP)
Time Frame: during MV
|
most high PEEP during MV
|
during MV
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Radovan Uvizl, UH Olomouc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
April 6, 2017
Study Registration Dates
First Submitted
April 7, 2017
First Submitted That Met QC Criteria
April 11, 2017
First Posted (Actual)
April 12, 2017
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 65/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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