Clinical trial NCT03850340: Evaluation of the Review of Automated Ventilator Data's Effect on the Incidence of Ventilator Associated Events in a Medical Surgical Intensive Care Unit
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Events
Keywords: Ventilator Associated Conditions
Infection Related Ventilator Associated Conditions
Probable Ventilator Associated Pneumonia
Lead sponsor: St. Joseph's/Candler Health System
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* any patients under the age of 18 or mechanically ventilated for \< 3days.

Primary outcomes:
measure: Incidence of Ventilator Associated Events
timeFrame: 03/01/2014 until 02/28/2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: