The END Perioperative Smoking Pilot Study

NCT ID: NCT02482233

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Smoking; Nicotine Addiction; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ENDD

6-week supply of disposable "NJOY" ENDDs (e-cigarettes)

• the number of e-cigarettes will be determined by equating the number of e-cigarettes to the number of cigarettes smoked per day (1 pack per day = 2 e-cigarettes per day = 14 e-cigarettes/week)
• veterans will be given detailed instructions for use and also instructed to start with the high nicotine content (4.5%) strength for three weeks, then decrease to the low nicotine content (2.4%) for two weeks, then switch to nicotine-free for the final week

Both groups will receive:

i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery

Group Type: EXPERIMENTAL

ENDD (NJOY)

Intervention Type: BEHAVIORAL

As described above.

telephone counseling

Intervention Type: BEHAVIORAL

Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.

brief advice

Intervention Type: BEHAVIORAL

Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."

brochure

Intervention Type: BEHAVIORAL

A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.

Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf

NRT (NicoDerm CQ)

A prescription for 6 weeks of transdermal nicotine replacement (on-formulary at the VA) in the following doses: For smokers of 10 cigarettes per day or more, a 3-week supply of 21 mg/d, 1-week supply of 14 mg/d, 1-week supply of 7 mg/d, and 1-week of 0mg/d. Smokers of <10 cigarettes per day, 3 weeks of 14 mg/d patches 2 weeks of 7 mg/d patches, and 1-week of 0mg/d.

Both groups will receive:

i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery

Group Type: ACTIVE_COMPARATOR

NRT (NicoDerm CQ)

Intervention Type: DRUG

As described above.

telephone counseling

Intervention Type: BEHAVIORAL

Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.

brief advice

Intervention Type: BEHAVIORAL

Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."

brochure

Intervention Type: BEHAVIORAL

A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.

Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf

Interventions

ENDD (NJOY)

As described above.

Intervention Type: BEHAVIORAL

NRT (NicoDerm CQ)

As described above.

Intervention Type: DRUG

telephone counseling

Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.

Intervention Type: BEHAVIORAL

brief advice

Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."

Intervention Type: BEHAVIORAL

brochure

A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.

Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf

Intervention Type: BEHAVIORAL

Other Intervention Names

electronic nicotine delivery device; NJOY e-cigarettes; nicotine patch

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan M Lee, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

UCSF / SFVAMC

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Countries

United States

References

Lee SM, Tenney R, Wallace AW, Arjomandi M. E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial. PeerJ. 2018 Sep 28;6:e5609. doi: 10.7717/peerj.5609. eCollection 2018.

Reference Type: RESULT

PMID: 30280019 (View on PubMed)

Related Links

https://peerj.com/articles/5609/

Full peer-reviewed results

Other Identifiers

14-15274

Identifier Type: -

Identifier Source: org_study_id