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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
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Smoking
Interventions: Behavioral: Informing surgical patients about CO monitoring
Behavioral: a brief intervention recommending preoperative abstinence from smoking

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Cigarette smokers scheduled for elective non-cardiac surgery were recruited from the preoperative evaluation clinic at Mayo Clinic Rochester.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    CO Reminder     no CO Reminder  
STARTED     82     87  
COMPLETED     82     87  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    CO Reminder     no CO Reminder     Total  
Number of Participants  
[units: participants]
  82     87     169  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     66     70     136  
>=65 years     16     17     33  
Age  
[units: years]
Mean ± Standard Deviation
  53  ± 12     53  ± 12     53  ± 12  
Gender  
[units: participants]
     
Female     40     47     87  
Male     42     40     82  
Region of Enrollment  
[units: participants]
     
United States     82     87     169  



  Outcome Measures

1.  Primary:   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. ]

2.  Primary:   Preoperative Carbon Monoxide Levels   [ Time Frame: the morning of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David O. Warner MD
Organization: Mayo Clinic
phone: 5072846277
e-mail: warner.david@mayo.edu


No publications provided by Mayo Clinic

Publications automatically indexed to this study:

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