Analysis of the Evolution of Mortality in an Intensive Care Unit

Epidemiological Analysis of the Evolution of the Case-mix and Mortality in the Intensive Care Unit of Hospital Universitario De Getafe (1991-2026)

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment.

Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU.

Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients.

That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit.

Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026

Study Overview

• Status: Recruiting
• Conditions: Mortality; Respiratory Failure; Neurologic Disorder; Sepsis Syndrome; Intensive Care Unit; Respiration, Artificial; Epidemiology

• Study Type: Observational
• Enrollment (Estimated): 25000

Contacts and Locations

• Study Contact: Name: Fernando Frutos-Vivar, MD; Phone Number: 462766 34916839360; Email: fernando.frutos@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Recruiting
      • Hospital Universitario de Getafe
      • Contact: Fernando Frutos-Vivar, MD; Phone Number: 462766 +34916839360; Email: fernando.frutos@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who required a admission to intensive care unit

Description

Inclusion Criteria:

• Patients admitted to intensive care unit

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit Mortality	Died during stay in the intensive care unit	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	Died during stay in the hospital	180 days
Mortality 28-day	Mortality at day 28 after admission in the Hospital	28 days from date of admission in the Hospital
Use of Mechanical ventilation	Proportion of patients who required mechanical ventilation (invasive and non-invasive) during stay in the intensive care unit	180 days
Length of stay in the intensive care unit	Stay in the intensive care unit	180 days
Length of stay in the hospital	Stay in the hospital	180 days
Complications/events during stay in the intensive care unit	Rate of complications/events occurred in the intensive care unit	180 days

Collaborators and Investigators

• Sponsor: Hospital Universitario Getafe
• Investigators: Principal Investigator: Fernando Frutos-Vivar, MD, Hospital Universitario de Getafe

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 1991
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mortality; Outcome; Intensive care units
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Inflammation; Respiration Disorders; Shock; Respiratory Insufficiency; Sepsis; Nervous System Diseases; Toxemia; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: Evolution mortality ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No