Clinical trial NCT03847155: Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
Official title: Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: nicotine patch
placebo
critically ill patients
delirium
prevention
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomized into two study groups, with the active substance and placebo.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of delirium episodes
timeFrame: maximum of 7 days
Secondary outcomes:
measure: Change in the number of days with delirium
timeFrame: maximum of 7 days
measure: Ventilator-hours
timeFrame: maximum of 7 days
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jan Neiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Granberg Axell 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. doi: 10.1034/j.1399-6576.2002.460616.x.
citation: 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.
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.
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.
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.