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Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Primary Purpose

Nicotine Dependence

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Nicotine patch

Placebo patch

About this trial

This is an interventional prevention trial for Nicotine Dependence focused on measuring nicotine patch, placebo, critically ill patients, delirium, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotine

Placebo

Arm Description

The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.

The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Ventilator-hours

The number of ventilator-hours will be observed in both groups of study subjects.

Full Information

NCT ID

NCT03847155

First Posted

February 18, 2019

Last Updated

February 8, 2021

Sponsor

University Hospital Ostrava

1. Study Identification

Unique Protocol Identification Number

NCT03847155

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 23, 2015 (Actual)

Primary Completion Date

January 31, 2021 (Actual)

Study Completion Date

February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

Keywords

nicotine patch, placebo, critically ill patients, delirium, prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The patients will be randomized into two study groups, with the active substance and placebo.

Masking

ParticipantCare ProviderInvestigator

Masking Description

The participant, care provider and investigator will be masked as far as the treatment provided is concerned.

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotine

Arm Type

Experimental

Arm Description

The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.

Intervention Type

Drug

Intervention Name(s)

Nicotine patch

Intervention Description

The patients will receive a nicotine patch for the period of a maximum of 7 days.

Intervention Type

Other

Intervention Name(s)

Placebo patch

Intervention Description

The patients will receive a placebo patch for the period of a maximum of 7 days.

Primary Outcome Measure Information:

Title

Incidence of delirium episodes

Description

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

Secondary Outcome Measure Information:

Title

Change in the number of days with delirium

Description

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

Title

Ventilator-hours

Description

The number of ventilator-hours will be observed in both groups of study subjects.

Time Frame

maximum of 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Neiser, MD

Organizational Affiliation

University Hospital Ostrava

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ostrava

City

Ostrava

State/Province

Moravian-Silesian Region

ZIP/Postal Code

70852

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The investigators do not plan to make individual participant data available to other researchers.

Citations:

PubMed Identifier

12059899

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.

Results Reference

background

PubMed Identifier

22480622

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.

Results Reference

background

PubMed Identifier

21494111

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.

Results Reference

background

PubMed Identifier

28375992

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.

Results Reference

background

PubMed Identifier

18282269

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.

Results Reference

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Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

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