Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 12:35 PM
Study NCT ID:
NCT02918500
Status:
TERMINATED
Last Update Posted:
2022-01-05
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Study Overview
Official Title:
Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to recruitment challenges.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications
Detailed Description:
The aim of this project is to
1. To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.
2. To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.
3. To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.
We therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications
To assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.
1. To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.
2. To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.
3. To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.
We therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications
To assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: