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

NCT ID: NCT01014455

Last Updated: 2011-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CO reminder

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

Group Type: EXPERIMENTAL

Informing surgical patients about CO monitoring

Intervention Type: 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

no CO reminder

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

Group Type: PLACEBO_COMPARATOR

a brief intervention recommending preoperative abstinence from smoking

Intervention Type: BEHAVIORAL

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

Interventions

Informing surgical patients about CO monitoring

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

Intervention Type: BEHAVIORAL

a brief intervention recommending preoperative abstinence from smoking

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients ≥ 18 yrs. scheduled for elective non-cardiac surgery at Mayo Clinic Rochester;

2. Current smoking, defined as > 100 cigarettes lifetime consumption and self-report of smoking every day.

Exclusion Criteria

1. An inability to understand consent procedures;

2. Inability to complete a written questionnaire.

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

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

David O Warner, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25057969 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22924451 (View on PubMed)

Other Identifiers

09-006998

Identifier Type: -

Identifier Source: org_study_id