I3PT Instituto de Investigación e Innovación Parc Taulí
Sabadell, Barcelona, 08208, Spain
NCT Number: NCT07153380
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.
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Notify Me18 year and older
All sexes
Observational
Sabadell, Barcelona, 08208, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During ICU admission
Daily levels of anxiety and depression symptoms- Assessed by Visual Analog Scale (VAS).
The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).
Time frame: During ICU admission
Daily levels of dyspnea and pain. - Assessed by Visual Analog Scale (VAS). The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).
Time frame: From the first documented data on discharge from the ICU for the first subject included in the study, to the last documented data on discharge from the ICU for the last patient included in the study, evaluated up to 24 months.
MoCA test
Corporacion Parc Tauli
Other
Critical Assessment of Respiratory, Physical and Emotional Distress in Critically Ill Patients With and Without Invasive Mechanical Ventilation
Acronym: CARE-ICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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