CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT07153380
NCT07153380N/ACompleted

Critical Assessment of Respiratory, Physical and Emotional Distress in Critically Ill Patients With and Without Invasive Mechanical Ventilation

Corporacion Parc Tauli·observational·Posted Sep 4, 2025·Updated Sep 4, 2025

In Brief

An observational study for ICU Ill Patients and Critical Illness. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Emotional distress is prevalent in ICU patients and may be influenced by physical symptoms such as dyspnea and pain, yet its evolution and interactions during ICU stay remain insufficiently explored. The main objective of this study is to investigate the trajectory of anxiety, sadness, dyspnea, and pain during ICU stay, as well as their associations with clinical and demographic factors. Moreover, the investigators will study the impact of emotional distress during ICU admission in the cognitive status of the ICU survivors at discharge. In this study the investigators will recover the data of 62 ICU patients who participated in 3 different studies lead by the research line of Characterization and Managment of the Post-Intensive Care Syndrome from the I3PT research Group of Translational Research in the Physiopathology of the Critically Ill Patients. In the 3 studies, emotional distress (anxiety and sadness), dyspnea, and pain were evaluated daily using visual analog scales once adequate consciousness was achieved (RASS -1 to +1). Cognitive status at ICU discharge was assessed using the Montreal Cognitive Assessment (MoCA). The datasets of the 3 studies will be revised and a new database will be generated with participants who have an assessment of emotional distress for at least 80% of the ICU length of stay with an optimal level of consciousness (RASS \>-1). New mixed-effects models will be used to explore the evolution of emotional and physical distress during ICU admission and the associations with invasive mechanical ventilation (IMV), and other demographic and clinical variables. Expected results: the investigators expect a better understanding of the evolution of anxiety and sadness symptoms during ICU stay and its relationship with the level of dyspnea and pain experienced by the critically ill patients during admission.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 4, 2025
Enrollment StartNov 1, 2018
Primary CompletionSep 14, 2024
Study CompletionSep 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 10 months ago