Monitoring of Exhaled Carbon Monoxide to Promote Pre-operative Smoking Cessation

NCT01014455 | Completed Results DMC

• 1 other identifier: 09-006998
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking causes 90% of all lung cancer deaths among men and 80% of lung cancer deaths in women. Surgery is a great opportunity to help patients quit smoking. Smokers are at increased risk for heart, lung, and wound complications around the time of surgery. Even a brief abstinence from smoking can produce benefits. Surgery can also motivate smokers to quit spontaneously. If the investigators can take advantage of this great opportunity, they may be able to help many smokers quit using simple means. However, currently most smokers continue to smoke cigarette on the morning before surgery, as shown by the measurement of exhaled carbon monoxide (CO) on the morning of surgery. CO is one of the many poisons in cigarette smoke. It only stays in the body for a few hours. By asking smokers to blow into a small machine, the investigators can test the CO level in the smokers' body and thus know if they have just smoked within the past few hours. The goal of this study is to determine the role of carbon monoxide monitoring as a means to decrease cigarette smoking before surgery. The investigators will identify a group of smokers who are scheduled for surgery and invite them to participate. One or two days before surgery, half of the patients will receive a brief advice about quit smoking. The other half of patients will be told that their CO will be checked before surgery, in addition to the brief advice. On the morning of surgery, the investigators will then check their CO level to determine if they have followed the advice. In order to have a better understanding about the factors influencing patients' intent to quit smoking, the investigators will ask all study participants to fill out a questionnaire. The questionnaire is constructed according to behavioral theories which provide good framework for studying people's intent and behavior. If the investigators are successful, they will determine how much of an impact the message of CO testing has on smoking before surgery. The investigators will also gain insights into facilitators and barriers to smoking cessation around the time of surgery. The brief intervention evaluated in this study has potential to be disseminated and to promote the long term health of surgical patients.

Conditions

Smoking

Keywords

surgery

Outcome Measures

Primary Outcomes (2)

• Preoperative Carbon Monoxide Levels

  the morning of surgery

• Exhaled CO Level Measured Immediately Prior to Surgery

  On the morning of surgery, as matter of clinical routine all patients receiving surgery requiring anesthesia services at one of the two main surgical facilities at Mayo Clinic Rochester and who self-report as a current smoker are asked about their typical cigarette consumption (cigarettes per day), if they have smoked cigarettes today, and have their exhaled CO levels measured (Micro Smokerlyzer; Bedfont, United Kingdom). This information is entered into the clinical record. The CO monitors are maintained by the Division of Respiratory Therapy, including regular calibration.

  The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.

Study Arms (2)

CO reminder

EXPERIMENTAL

A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery

Behavioral: Informing surgical patients about CO monitoring

no CO reminder

PLACEBO COMPARATOR

a brief intervention that recommends fasting but does not mention that CO will be checked

Behavioral: a brief intervention recommending preoperative abstinence from smoking

Interventions

Informing surgical patients about CO monitoring BEHAVIORAL

A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery

CO reminder

a brief intervention recommending preoperative abstinence from smoking BEHAVIORAL

a brief intervention that recommends fasting but does not mention that CO will be checked

no CO reminder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 yrs. scheduled for elective non-cardiac surgery at Mayo Clinic Rochester;
• Current smoking, defined as \> 100 cigarettes lifetime consumption and self-report of smoking every day.

You may not qualify if:

• An inability to understand consent procedures;
• Inability to complete a written questionnaire.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Shi Y, Ehlers S, Warner DO. The theory of planned behavior as applied to preoperative smoking abstinence. PLoS One. 2014 Jul 24;9(7):e103064. doi: 10.1371/journal.pone.0103064. eCollection 2014.

  PMID: 25057969 DERIVED

• Shi Y, Ehlers S, Hinds R, Baumgartner A, Warner DO. Monitoring of exhaled carbon monoxide to promote preoperative smoking abstinence. Health Psychol. 2013 Jun;32(6):714-7. doi: 10.1037/a0029504. Epub 2012 Aug 27.

  PMID: 22924451 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Study subjects received the additional questionnaire on smoking behavior, which itself could heighten awareness of perioperative tobacco use issues and could be viewed as an additional intervention.

Results Point of Contact

• Title: David O. Warner MD
• Organization: Mayo Clinic

warner.david@mayo.edu

5072846277

Study Officials

• David O Warner, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 17, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 22, 2011
• Results First Posted: August 22, 2011

Record last verified: 2011-07

Locations

US (1)