Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery (PATCHIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572646
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Mutualiste de Grenoble

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Smoking is associated with a higher rate of surgical complications. For example, in orthopedics, the risk of complications is 31% in smokers against 5% in non-smokers. The management of this addiction is recommended and particularly interesting in scheduled surgery, because it allows smoking cessation well before the procedure. However, for patients who cannot consider this smoking cessation, the mere information of the risk cannot be sufficient and a real strategy must be constructed and evaluated.

Currently, studies results indicate that a patient reducing the number of smoked cigarettes will unconsciously modify their smoking behaviour to obtain the usual nicotine level, this effect is called self-titration. Conversely, nicotine replacement while continuing consumption could induce an improvement in smoking behaviour, therefore less intoxication which would be beneficial in terms of reduction of post-operative complications. This study seeks to assess the effectiveness of a systematic proposition of nicotine replacement therapy (NRT) in regular smokers. Tobacco addiction specialists have demonstrated that intoxication and dependence are well correlated with the exhaled carbon monoxide (CO) level, so this measurement will be used in addition to the patient's interview.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: NRT proposition and exhaled CO measurement Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Benefit of a Systematic Proposition of Nicotine Replacement Therapy Preoperatively for Patients Undergoing Planned Surgery and With Tobacco or Cannabis Addiction, Regardless of the Intention to Quit
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
NRT proposition and exhaled CO measurement Other: NRT proposition and exhaled CO measurement

Nicotine replacement therapy is proposed to every patient included in the study.

Whether the patient accepts the therapy or not, exhaled carbon monoxide is measured at the preoperative consultation (about 15 days before surgery) and the day of surgery by a nurse. These two measures are compared to assess efficacy of nicotine replacement therapy.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of a systematic proposition of nicotine replacement therapy, regardless of the intention to quit Change in exhaled carbon monoxide level between the two measurements, assessed by a carbon monoxide breath monitor [ Time Frame: At inclusion, and before surgery ]

Secondary Outcome Measures :
  1. Number of patients who refuse nicotine replacement therapy [ Time Frame: At inclusion ]
  2. Effect of nicotine replacement therapy on the type of analgesics administrated [ Time Frame: At inclusion, before surgery, and 2 days after surgery ]
  3. Effect of nicotine replacement therapy on the duration of analgesics administrated [ Time Frame: At inclusion, before surgery, and 2 days after surgery ]
  4. Effect of nicotine replacement therapy on the dose of analgesics administrated [ Time Frame: At inclusion, before surgery, and 2 days after surgery ]
  5. Number of smoking cessations [ Time Frame: 2 days after surgery ]
  6. Efficacy of a systematic proposition of nicotine replacement therapy, depending on the intention to quit Change in exhaled carbon monoxide level between the two measurements, assessed by a carbon monoxide breath monitor [ Time Frame: At inclusion, and before surgery ]
    Subgroup analysis of the primary endpoint according to predefined groups


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who smokes at least one cigarette or cannabis joint per day, every day
  • Patient received for nurse consultation at least 48 hours before surgery
  • Patient planned to undergo surgery, with entry the day of surgery and 1 day of post-operative hospitalisation
  • Patient in physical capacity and willing to undergo exhaled carbon monoxide measurement
  • For patients with one of the following chronic diseases: diabetes, Chronic Obstructive Pulmonary Disease, glucose intolerance, hemolytic anemia, asthma and dilation of the bronchi, these diseases must be stable
  • Signature of the specific study informed consent
  • Patient affiliated or beneficiary of social security system

Exclusion Criteria:

  • Inability to submit to study follow-up for geographic, social or psychological reasons
  • Patient already included in an interventional clinical research protocol
  • Patients protected by French law from clinical research inclusion (pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation)
  • Patient using nicotine substitutes before the nurse consultation
  • Alcohol consumption six hours before the exhaled carbon monoxide measurement
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572646


Contacts
Layout table for location contacts
Contact: Aurélie MILLERIOUX 476707280 ext +33 a.millerioux@ghm-grenoble.fr

Locations
Layout table for location information
France
Groupe hospitalier Mutualiste de Grenoble Recruiting
Grenoble, France, 38028
Contact: Aurélie MILLERIOUX    476707280    a.millerioux@ghm-grenoble.fr   
Principal Investigator: Estelle COTTE-RAFFOUR         
Sponsors and Collaborators
Groupe Hospitalier Mutualiste de Grenoble
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Groupe Hospitalier Mutualiste de Grenoble
ClinicalTrials.gov Identifier: NCT04572646    
Other Study ID Numbers: 2020/03-ECR-GHMG
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Mutualiste de Grenoble:
postoperative complication
nicotine replacement therapy
exhaled carbon monoxide level