Clinical Trials Directory

Trials / Completed

CompletedNCT07153380

Evolution of Physical and Emotional Distress in ICU

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

Status
Completed
Phase
Study type
Observational
Enrollment
62 (actual)
Sponsor
Corporacion Parc Tauli · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2018-11-01
Primary completion
2024-09-14
Completion
2024-09-15
First posted
2025-09-04
Last updated
2025-09-04

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07153380. Inclusion in this directory is not an endorsement.