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

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.

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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