Effect of Daily Nicotine Patch Application on Mechanical Ventilation Weaning in Smoking Patients

Study Overview
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Brief Summary
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Nicotine patches are frequently used in smoking patients during their stay in the ICU in order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical ventilation weaning. Until now the effectiveness of this treatment has not been proven. The aim of this study (NICOREA study) is to determine if a difference exists on the duration of mechanical ventilation once patients receive or not a nicotine substitute.

Detailed Description
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Six hundred mechanically ventilated patients are going to be enrolled to receive nicotine or placebo during a 24 month period in 14 centers in France.

Official Title
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Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit

Conditions
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Smoking, Mechanical Ventilation, Intensive Care

Intervention / Treatment
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* Drug: Nicotine patch
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 et 80 yrs SOFA score below or equal to 16 at randomization time Patient expected to be mechanically ventilated for at least 24hrs Patient known to be usually smoking more than 10 cigarettes per day according to her/him or to a next of kin Consent obtained from the patient or a next of kin. Exclusion Criteria: Patients having been in the ICU for more than 72 hours or mechanically ventilated since more than 48 hours Isolated brain trauma Patients weaned from tobacco since more than 21 days Patients smoking only pipe, cigars or cannabis Chronic skin diseases (psoriasis, dermatitis, etc) Patients receiving other products containing nicotine Patients not understanding French Patients with severe hearing deficiency Mechanical ventilation weaning using an expert system Disease with short term fatal issue Pregnancy Patient depending on other persons for most every day actions Myocardial infarction within 3 months, ventricular arrhythmia's Stroke during the 3 last months Known hypersensibility to nicotine or patches

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine<br>One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale. | Drug: Nicotine patch<br>* One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days<br>* Other names: Nicorette;|
| Placebo Comparator: Placebo<br>One or two patch(es) with placebo | Drug: Placebo<br>* One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days<br>* Other names: Nicorette placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of mechanical ventilation expressed in hours | Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours | 48 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the ICU expressed in day(s) |  | Within the first 30 days | 
| Number of failure of mechanical ventilation weaning |  | Within the first 30 days | 
| Incidence of score above +1 of the RASS scale measured every 4 hours |  | Within the first 30 days | 
| Number of days with delirium assessed by the CAM-ICU score |  | Within the first 30 days | 
| Number of hours under sedation below RASS -4, between -3,-2, -2,+1 indexed by the overall duration of sedation |  | Within the first 30 days | 
| Number of self-extubation(s) |  | Within the first 30 days | 
| Number of pneumonia acquired during mechanical ventilation |  | Within the first 30 days | 
| SOFA score |  | between 48 and 72 hrs | 
| Tobacco weaning rate at hospital discharge |  | Within the first 120 days | 
| 28th day mortality rate |  | betwwen 28th and 48th days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette, tobacco, mechanical ventilation, nicotine