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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01014455
First received: November 13, 2009
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Informing surgical patients about CO monitoring
Behavioral: a brief intervention recommending preoperative abstinence from smoking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monitoring of Exhaled Carbon Monoxide to Promote Pre-operative Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Preoperative Carbon Monoxide Levels [ Time Frame: the morning of surgery ] [ Designated as safety issue: No ]
  • Exhaled CO Level Measured Immediately Prior to Surgery [ Time Frame: The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days. ] [ Designated as safety issue: No ]
    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.


Enrollment: 169
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Behavioral: 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
Placebo Comparator: no CO reminder
a brief intervention that recommends fasting but does not mention that CO will be checked
Behavioral: a brief intervention recommending preoperative abstinence from smoking
a brief intervention that recommends fasting but does not mention that CO will be checked

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014455

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David O Warner, MD Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David O. Warner, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01014455     History of Changes
Other Study ID Numbers: 09-006998
Study First Received: November 13, 2009
Results First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
surgery

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014