Smoking CessationPATCHIRNCT04572646
Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery
A study testing NRT proposition and exhaled CO measurement in people with Smoking Cessation, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- NRT proposition and exhaled CO measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 24 Aug 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Smoking Cessation
- Being tested
- NRT proposition and exhaled CO measurement
- Keywords
- postoperative complication, nicotine replacement therapy, exhaled carbon monoxide level
- Medical subject headings
- Smoking Cessation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRT proposition and exhaled CO measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NRT proposition and exhaled CO measurement | Other | Not described Receives: Other: NRT proposition and exhaled CO measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion, and before surgery
Secondary outcomes (6)
Number of patients who refuse nicotine replacement therapy
Measured: At inclusion
Effect of nicotine replacement therapy on the type of analgesics administrated
Measured: At inclusion, before surgery, and 2 days after surgery
Effect of nicotine replacement therapy on the duration of analgesics administrated
Measured: At inclusion, before surgery, and 2 days after surgery
Effect of nicotine replacement therapy on the dose of analgesics administrated
Measured: At inclusion, before surgery, and 2 days after surgery
Number of smoking cessations
Measured: 2 days after surgery
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
Subgroup analysis of the primary endpoint according to predefined groups
Measured: At inclusion, and before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start24 Aug 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Why it stopped: Recruitment goal not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Mutualiste de Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572646
- Sponsor's protocol ID
- 2020/03-ECR-GHMG
- Acronym
- PATCHIR
- Status last verified
- Mar 2022
- First submitted
- 15 Sep 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04572646
- Acronym / sponsor ID
- PATCHIR / 2020/03-ECR-GHMG
- Conditions
- Smoking Cessation
- Keywords
- postoperative complication, nicotine replacement therapy, exhaled carbon monoxide level
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment goal not feasible
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Groupe Hospitalier Mutualiste de GrenobleUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRT proposition and exhaled CO measurement | Other | Other: NRT proposition and exhaled CO measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRT proposition and exhaled CO measurementNicotine 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. | Other | NRT proposition and exhaled CO measurement |
Primary outcome
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
6 secondary outcomes
Number of patients who refuse nicotine replacement therapy
Time frame: At inclusion
Effect of nicotine replacement therapy on the type of analgesics administrated
Time frame: At inclusion, before surgery, and 2 days after surgery
Effect of nicotine replacement therapy on the duration of analgesics administrated
Time frame: At inclusion, before surgery, and 2 days after surgery
Effect of nicotine replacement therapy on the dose of analgesics administrated
Time frame: At inclusion, before surgery, and 2 days after surgery
Number of smoking cessations
Time frame: 2 days after surgery
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
Results and safety
The study was stopped early (reason given: Recruitment goal not feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NRT proposition and exhaled CO measurement in people with Smoking Cessation, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment goal not feasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.