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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine | Active Comparator | One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale. |
|
| Placebo | Placebo Comparator | One or two patch(es) with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shohreh Azimi | Contact | +33 1 44 84 17 79 | shohreh.azimi@sls.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Didier Journois, M.D. Ph.D. | AP-HP, Université René Descartes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hegp-Aphp | Recruiting | Paris | France | 75908 | France |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 |
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| Placebo | Drug | One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days |
|
|
| 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 |
| Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |