Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Drug: Nicotine patch
* Other: Placebo patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a surgical procedure - urological, surgical, trauma surgery, orthopedic surgery, dental surgery) Age 18 years and above Patient with an assumption of nicotine abstinence (smoking a minimum 10 cigarettes/day). Ex-smokers (if they stopped smoking less than 30 days prior to surgery) An assumption of hospitalization at the intensive care unit (ICU) after surgery Signed Informed consent Exclusion Criteria: Age ˂ 18 years Non-signing of the informed consent Patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke Patients with psychiatric diseases Nicotine, Curapor or Hydrocoll allergy Patient with a heart attack, unstable angina pectoris or patients with a serious heart arrhythmia Pregnant and breastfeeding patients Patients with nicotine treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized into two study groups, with the active substance and placebo.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine<br>The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days. | Drug: Nicotine patch<br>* The patients will receive a nicotine patch for the period of a maximum of 7 days.<br>|
| Placebo Comparator: Placebo<br>The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days. | Other: Placebo patch<br>* The patients will receive a placebo patch for the period of a maximum of 7 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | maximum of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | maximum of 7 days | 
| Ventilator-hours | The number of ventilator-hours will be observed in both groups of study subjects. | maximum of 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine patch, placebo, critically ill patients, delirium, prevention