Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Nicotine Dependence Clinical Trial

Official title:

Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847155
• Other study ID #: KARIM-09-NICOTINE
• Secondary ID: 2014-003720-43
• Status: Completed
• Phase: N/A
• Start date: September 23, 2015
• Est. completion date: February 8, 2021

Study information

• Verified date: February 2021
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 8, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine patch
The patients will receive a nicotine patch for the period of a maximum of 7 days.

Other:
• Placebo patch
The patients will receive a placebo patch for the period of a maximum of 7 days.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

Bledowski J, Trutia A. A review of pharmacologic management and prevention strategies for delirium in the intensive care unit. Psychosomatics. 2012 May-Jun;53(3):203-11. doi: 10.1016/j.psym.2011.12.005. Epub 2012 Apr 4. Review. — View Citation

Cartin-Ceba R, Warner DO, Hays JT, Afessa B. Nicotine replacement therapy in critically ill patients: a prospective observational cohort study. Crit Care Med. 2011 Jul;39(7):1635-40. doi: 10.1097/CCM.0b013e31821867b8. — View Citation

Granberg Axèll AI, Malmros CW, Bergbom IL, Lundberg DB. Intensive care unit syndrome/delirium is associated with anemia, drug therapy and duration of ventilation treatment. Acta Anaesthesiol Scand. 2002 Jul;46(6):726-31. — View Citation

Jablonski J, Gray J, Miano T, Redline G, Teufel H, Collins T, Pascual-Lopez J, Sylvia M, Martin ND. Pain, Agitation, and Delirium Guidelines: Interprofessional Perspectives to Translate the Evidence. Dimens Crit Care Nurs. 2017 May/Jun;36(3):164-173. doi: 10.1097/DCC.0000000000000239. — View Citation

Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. A comparison of the CAM-ICU and the NEECHAM Confusion Scale in intensive care delirium assessment: an observational study in non-intubated patients. Crit Care. 2008;12(1):R16. doi: 10.1186/cc6790. Epub 2008 Feb 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ventilator-hours	The number of ventilator-hours will be observed in both groups of study subjects.	maximum of 7 days

External Links

•   Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit