The END Perioperative Smoking Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | August 2015 |
| End Date: | September 2016 |
A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes
and telephone counselling (compared to transdermal nicotine replacement and telephone
counselling) as a harm-reduction tool that may lead to increased smoking cessation in the
perioperative setting in smokers presenting for elective surgery at the San Francisco
Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes
over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit,
hospital length-of-stay, postoperative complications within the first 30-days, and smoking
status 8-weeks after randomization. This pilot study is designed to provide the preliminary
data necessary to plan and fund a larger-scale randomized clinical trial that will assess the
utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is
to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking
cessation, specifically in the perioperative setting where the risks of continued smoking are
great and the motivation to stop is high.
and telephone counselling (compared to transdermal nicotine replacement and telephone
counselling) as a harm-reduction tool that may lead to increased smoking cessation in the
perioperative setting in smokers presenting for elective surgery at the San Francisco
Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes
over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit,
hospital length-of-stay, postoperative complications within the first 30-days, and smoking
status 8-weeks after randomization. This pilot study is designed to provide the preliminary
data necessary to plan and fund a larger-scale randomized clinical trial that will assess the
utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is
to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking
cessation, specifically in the perioperative setting where the risks of continued smoking are
great and the motivation to stop is high.
It is well-known that smokers suffer more complications and higher risk of mortality after
surgery than non-smokers. Despite this knowledge, it is unclear what clinicians can do to
minimize this risk. Surgery represents a 'teachable moment' that might encourage smokers to
engage in permanent cessation. Several small trials have shown that smoking cessation
interventions can increase smoking cessation and reduce postoperative complications,
particularly wound-healing complications, which can have an absolute risk reduction of up to
25%. Smoking cessation initiated in the perioperative period can also promote long-term
smoking cessation. Despite the benefits of comprehensive smoking cessation interventions
including nicotine replacement therapy, current standard of care at the SFVAMC does not
routinely include specific preoperative smoking cessation pharmacotherapy or counselling.
Although there is an urgent need for more data, e-cigarettes have been proposed as an
alternative to nicotine replacement therapy that are at least as effective for smoking
cessation, and may be more acceptable to some patients.
The main hypothesis of this pilot study is that the use of e-cigarettes and telephone
counselling, compared to telephone counselling and transdermal nicotine replacement, in the
perioperative period results in increased smoking cessation on the day of surgery and at
8-weeks after randomization in smokers presenting for elective surgery. As secondary
hypotheses, the study will also assess the acceptability of e-cigarettes versus nicotine
patches, postoperative complications within the first 30-days, length-of-stay in the PACU and
hospital length-of-stay. The investigators will examine the above hypotheses through the
following aims:
" Aim 1) To determine how e-cigarettes plus counselling compare to transdermal nicotine
replacement plus counselling for the achievement of smoking cessation, when introduced prior
to elective surgery in veterans.
The investigators plan to carry-out a pilot randomized controlled trial with parallel design
comparing e-cigarettes and telephone counselling with transdermal nicotine replacement and
telephone counselling. Our primary outcome is smoking cessation on the day of surgery, as
confirmed biochemically by exhaled carbon monoxide. Smoking reduction (self-reported
cigarettes per day) of 50% or more and bedside spirometry readings will be assessed as
secondary outcomes.
" Aim 2) To determine the acceptability of e-cigarettes amongst veterans as an aid for
smoking cessation and to determine the feasibility of recruitment, randomization, and
follow-up procedures in preparation for large-scale trial.
Through implementation of this pilot trial, the investigators will determine the feasibility
and acceptability of e-cigarettes for smoking cessation perioperatively in the veteran
population and obtain the preliminary data necessary to run a larger trial on the
effectiveness of e-cigarettes as a perioperative smoking cessation aid.
" Aim 3) To determine the safety of e-cigarettes as a harm reduction strategy to achieve
short-term perioperative smoking cessation.
The investigators plan to improve the overall knowledge of the safety of short-term
e-cigarettes use through careful surveillance for adverse events and side effects.
" Aim 4) To determine if e-cigarette use preoperatively is associated with a lower risk of
complications postoperatively.
The investigators plan to measure the following secondary outcomes: postoperative
complications and mortality within the first 30 days, post-anesthesia care unit (PACU)
length-of-stay, and hospital length-of-stay. This will help us understand if e-cigarettes
have the potential to be used for harm-reduction perioperatively.
surgery than non-smokers. Despite this knowledge, it is unclear what clinicians can do to
minimize this risk. Surgery represents a 'teachable moment' that might encourage smokers to
engage in permanent cessation. Several small trials have shown that smoking cessation
interventions can increase smoking cessation and reduce postoperative complications,
particularly wound-healing complications, which can have an absolute risk reduction of up to
25%. Smoking cessation initiated in the perioperative period can also promote long-term
smoking cessation. Despite the benefits of comprehensive smoking cessation interventions
including nicotine replacement therapy, current standard of care at the SFVAMC does not
routinely include specific preoperative smoking cessation pharmacotherapy or counselling.
Although there is an urgent need for more data, e-cigarettes have been proposed as an
alternative to nicotine replacement therapy that are at least as effective for smoking
cessation, and may be more acceptable to some patients.
The main hypothesis of this pilot study is that the use of e-cigarettes and telephone
counselling, compared to telephone counselling and transdermal nicotine replacement, in the
perioperative period results in increased smoking cessation on the day of surgery and at
8-weeks after randomization in smokers presenting for elective surgery. As secondary
hypotheses, the study will also assess the acceptability of e-cigarettes versus nicotine
patches, postoperative complications within the first 30-days, length-of-stay in the PACU and
hospital length-of-stay. The investigators will examine the above hypotheses through the
following aims:
" Aim 1) To determine how e-cigarettes plus counselling compare to transdermal nicotine
replacement plus counselling for the achievement of smoking cessation, when introduced prior
to elective surgery in veterans.
The investigators plan to carry-out a pilot randomized controlled trial with parallel design
comparing e-cigarettes and telephone counselling with transdermal nicotine replacement and
telephone counselling. Our primary outcome is smoking cessation on the day of surgery, as
confirmed biochemically by exhaled carbon monoxide. Smoking reduction (self-reported
cigarettes per day) of 50% or more and bedside spirometry readings will be assessed as
secondary outcomes.
" Aim 2) To determine the acceptability of e-cigarettes amongst veterans as an aid for
smoking cessation and to determine the feasibility of recruitment, randomization, and
follow-up procedures in preparation for large-scale trial.
Through implementation of this pilot trial, the investigators will determine the feasibility
and acceptability of e-cigarettes for smoking cessation perioperatively in the veteran
population and obtain the preliminary data necessary to run a larger trial on the
effectiveness of e-cigarettes as a perioperative smoking cessation aid.
" Aim 3) To determine the safety of e-cigarettes as a harm reduction strategy to achieve
short-term perioperative smoking cessation.
The investigators plan to improve the overall knowledge of the safety of short-term
e-cigarettes use through careful surveillance for adverse events and side effects.
" Aim 4) To determine if e-cigarette use preoperatively is associated with a lower risk of
complications postoperatively.
The investigators plan to measure the following secondary outcomes: postoperative
complications and mortality within the first 30 days, post-anesthesia care unit (PACU)
length-of-stay, and hospital length-of-stay. This will help us understand if e-cigarettes
have the potential to be used for harm-reduction perioperatively.
Inclusion Criteria:
- adults (age >18)
- any gender
- scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical
Center (SFVAMC)
- daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in
the last 7 days
- presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively
Exclusion Criteria:
- emergency surgery (booked <24 hours preoperatively)
- consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or
marijuana only
- already enrolled in a smoking cessation trial
- current smoking cessation pharmacotherapy
- daily user of e-cigarettes
- previous adverse reaction to e-cigarette or transdermal nicotine
- poor proficiency of English language¸as indicated by need for an interpreter
(including family members) at the preadmission visit
- lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by
consent for surgery and other medical procedures being obtained from a substitute
decision maker
- pregnant or breastfeeding
- unstable cardiac condition (unstable angina, unstable arrhythmia)
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