Trial Outcomes & Findings for Monitoring of Exhaled Carbon Monoxide to Promote Pre-operative Smoking Cessation (NCT NCT01014455)

NCT ID: NCT01014455

Last Updated: 2011-08-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 169 participants
• Primary outcome timeframe: the morning of surgery
• Results posted on: 2011-08-22

Participant Flow

Cigarette smokers scheduled for elective non-cardiac surgery were recruited from the preoperative evaluation clinic at Mayo Clinic Rochester.

Inform consent was obtained after data collection(approved by the IRB) because informing patients of the study at time of enrollment would have required providing information making it impossible to evaluate the hypothesis. Study records from patients who declined informed consent (n=14) were destroyed and are not included in the analysis.

Participant milestones

Measure	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	no CO Reminder a brief intervention that recommends fasting but does not mention that CO will be checked
Overall Study STARTED	82	87
Overall Study COMPLETED	82	87
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CO Reminder n=82 Participants 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 n=87 Participants a brief intervention that recommends fasting but does not mention that CO will be checked	Total n=169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants	70 Participants n=7 Participants	136 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age Continuous	53 years STANDARD_DEVIATION 12 • n=5 Participants	53 years STANDARD_DEVIATION 12 • n=7 Participants	53 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	47 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	87 participants n=7 Participants	169 participants n=5 Participants

PRIMARY outcome

Timeframe: the morning of surgery

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: 5 participants did not complete CO measures and were excluded from the analysis of primary outcome

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.

Outcome measures

Measure	CO Reminder n=80 Participants 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 n=84 Participants a brief intervention that recommends fasting but does not mention that CO will be checked
Exhaled CO Level Measured Immediately Prior to Surgery	9.7 ppm Standard Deviation 8.0	9.3 ppm Standard Deviation 6.6

Adverse Events

CO Reminder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no CO Reminder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David O. Warner MD

Mayo Clinic

Phone: 5072846277

Email: warner.david@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place