Ventilator-Associated Pneumonia in Critically Ill COVID-19 vs. Non-COVID-19 Patients

NCT05972980 | Completed

• 1 other identifier: MR-VAP-C19
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic has led to an increased incidence of ventilator-associated pneumonia (VAP) among critically ill patients. However, in a context of high prevalence of multidrug-resistant organisms (MDROs) there is a lack of direct comparison between the incidence of VAP in COVID-19 and non-COVID-19 cohorts. The investigators conducted a prospective, single-center cohort study comparing COVID-19 patients admitted to the intensive care unit (ICU) of the Città della Salute e della Scienza University Hospital in Turin, Italy, between March 2020 and December 2021 (COVID-19 group), with a historical cohort of ICU-mixed patients admitted between June 2016 and March 2018 (NON-COVID-19 group).

Conditions

Infections; Critical Illness; Superinfection; Organ Failure, Multiple; Ventilator Associated Pneumonia; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality within the first 28 days from ICU admission

  28 days

Secondary Outcomes (9)

• ICU mortality

  From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months

• Hospital mortality

  From date of enrollment until the date of hospital discharge, assessed up to 6 months

• Mechanical ventilation days

  From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months

• Ventilator acquired pneumonia incidence

  From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months

• Ventilator acquired pneumonia incidence

  28 days

Study Arms (2)

Non-COVID-19 cohort

Patients with Ventilator Acquired Pneumonia without COVID-19. The patients belonging to the NON-COVID cohort were admitted to three intensive care units at Molinette Hospital (Turin, Italy): * General Intensive Care Unit - admitting primarily medically critical patients and a smaller proportion of surgical patients, originating from the Hospital's Emergency Department or other Intensive Care Units in Piedmont. It serves as the regional referral center for Extracorporeal Membrane Oxygenation (ECMO). * Emergency Department - Intensive Care Unit (PSAR) - admitting both medical and surgical patients in urgent conditions. * Cardiac - Intensive Care Unit- admitting patients undergoing elective or emergency cardio-surgical interventions, and serving as a referral center for heart and lung transplants and the implantation of external ventricular assists.

COVID-19 cohort

Patients with Ventilator Acquired Pneumonia with COVID-19. Confirmation of pneumonia was achieved by using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique on a sample collected from the lower respiratory tract. The COVID-19 cohort consists of patients admitted at the "Città della Salute e della Scienza" University Hospital (Turin, Italy) in two intensive care units at Molinette Hospital, dedicated to treating critically ill patients with COVID-19.

Other: COVID-19

Interventions

COVID-19 OTHER

The investigators stratified our population based on COVID-19 virus positivity to identify any risk factors in this population compared to the NON-COVID-19 population.

COVID-19 cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with ventilator-acquired pneumonia admitted to the intensive care unit of the primary hospital "Molinette," Città della Salute e della Scienza, Turin, Italy.

You may qualify if:

• All adult patients diagnosed with ventilator-associated pneumonia
• Patients admitted to the intensive care units
• Patients who underwent mechanical ventilation for a duration longer than 48 hours

You may not qualify if:

• Patients in extreme end-of-life conditions
• Pregnant individuals
• Patients under 18 years of age
• Patients who did not meet the diagnosis criteria for ventilator-associated pneumonia
• Patients who underwent mechanical ventilation for a duration equal to or shorter than 48 hours
• Ventilator-associated tracheobronchitis

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10100, Italy

Location

MeSH Terms

Conditions

Infections; Critical Illness; Superinfection; Multiple Organ Failure; Pneumonia, Ventilator-Associated; Shock, Septic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Opportunistic Infections; Shock; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Luca Brazzi

  University of Torino

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 2, 2023
• Study Start: January 1, 2016
• Primary Completion: January 1, 2016
• Study Completion: December 31, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

IT (1)