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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03111303
Other study ID # 65/16
Secondary ID
Status Completed
Phase N/A
First received April 7, 2017
Last updated October 24, 2017
Start date January 1, 2011
Est. completion date April 6, 2017

Study information

Verified date October 2017
Source University Hospital Olomouc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2654
Est. completion date April 6, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Mechanical Ventilation Pressure High

Intervention

Device:
mechanical ventilation
Connection to mechanical ventilator

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Olomouc

Outcome

Type Measure Description Time frame Safety issue
Other Inspiratory pressure most high inspiratory pressure during MV during MV
Other Positive end expiratory pressure (PEEP) most high PEEP during MV during MV
Primary length of mechanical ventilation days of MV during MV
Secondary ICU length of stay length of stay in ICU 1 month
Secondary Hospital length of stay (LOS) length of hospital stay 1 month
Secondary Mortality mortality during Hospital LOS 1 month
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