The primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.
Patients in a group with medical intervention receive nicotine patch within 24 hours after surgery. The nicotine patch is replaced every day. Delirium is evaluated every day by the Confusion Assessment Method (CAM) - ICU test. The maximum length of intervention is 7 days. Patients in a group with placebo receive a placebo patch within 24 hours after surgery. This patch is replaced every day. Delirium is evaluated in the same way - CAM - ICU test. The maximum length of the placebo intervention is 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
52
The patients will receive a nicotine patch for the period of a maximum of 7 days.
The patients will receive a placebo patch for the period of a maximum of 7 days.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Incidence of delirium episodes
The number of delirium episodes, defined according to the CAM-ICU test, in the course of the seven days with the patch attached will be measured in both groups of study subjects.
Time frame: maximum of 7 days
Change in the number of days with delirium
Change in the number of days with delirium, defined according to the CAM-ICU test, by 20%, in the course of the seven days with the patch attached among the study subjects with the nicotine patch.
Time frame: maximum of 7 days
Ventilator-hours
The number of ventilator-hours will be observed in both groups of study subjects.
Time frame: maximum of 7 days
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