Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Nicotine patch; Other: Placebo patch

• Registration Number: NCT03847155
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study Start: 2015-09-23
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2021-01-31
• Status Verified: 2021-02
• Study Completion: 2021-02-08
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine	Nicotine patch	The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.
Placebo	Placebo patch	The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.

Primary Outcome Measures

Name	Time	Method
Incidence of delirium episodes	maximum of 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Ventilator-hours	maximum of 7 days	The number of ventilator-hours will be observed in both groups of study subjects.
Change in the number of days with delirium	maximum of 7 days	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.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia