Mechanical Ventilation Pressure HighNCT03111303
Mechanical Ventilation Parameters in HAP Patients
An observational study of Mechanical Ventilation Pressure High, run by University Hospital Olomouc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Pressure High
- What is being tested?
- mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 2,654 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 6 Apr 2017
- 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: 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.
Who may be able to join
- Age 18+
- Need of Mechanical ventilation (Pressure controlled mechanical ventilation or Pressure support ventilation)
Who cannot join
- Organ donor
- Need Volume controlled mechanical ventilation
- no mechanical ventilation
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Ventilation Pressure High
- Being tested
- mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationDevice
Connection to mechanical ventilator
| Study group | Role | What they receive |
|---|---|---|
| HAP patients | Mechanical ventilation, patients fulfilled HAP criteria Receives: Device: mechanical ventilation | |
| non HAP patients | Mechanical ventilation, patients without HAP Receives: Device: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of mechanical ventilation
days of MV
Measured: during MV
Secondary outcomes (3)
ICU length of stay
length of stay in ICU
Measured: 1 month
Hospital length of stay (LOS)
length of hospital stay
Measured: 1 month
Mortality
mortality during Hospital LOS
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Jan 2011
- Primary completion31 Dec 2016
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation Pressure HighStudies 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
- 2,654 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radovan Uvizl, University Hospital Olomouc
- Investigators
- Radovan Uvizl, Principal investigator, UH Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111303
- Sponsor's protocol ID
- 65/16
- Status last verified
- Oct 2017
- First submitted
- 7 Apr 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nosocomial Pneumonia as a Factor Influencing Parameters of Mechanical Ventilation: Results of a Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT03111303
- Acronym / sponsor ID
- 65/16
- Conditions
- Mechanical Ventilation Pressure High
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,654 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 12 Apr 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAP patients | – | Device: mechanical ventilationMechanical ventilation, patients fulfilled HAP criteria |
| non HAP patients | – | Device: mechanical ventilationMechanical ventilation, patients without HAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 18+
- Need of Mechanical ventilation (Pressure controlled mechanical ventilation or Pressure support ventilation)
Key exclusion criteria (3 listed)
- Organ donor
- Need Volume controlled mechanical ventilation
- no mechanical ventilation
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 |
|---|---|---|
| mechanical ventilationConnection to mechanical ventilator | Device | HAP patients, non HAP patients |
Primary outcome
length of mechanical ventilation
Time frame: during MV
days of MV
3 secondary outcomes
ICU length of stay
Time frame: 1 month
Hospital length of stay (LOS)
Time frame: 1 month
Mortality
Time frame: 1 month
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 26 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Radovan Uvizl principal investigator
UH Olomouc
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Pressure High, run by University Hospital Olomouc.
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 2 inclusion and 3 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 26 Oct 2017. 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?
length of mechanical ventilation (time frame: during MV). 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 26 Oct 2017.