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

University of Paris 5 - Rene Descartes

Status and phase: Unknown; Phase 4

Conditions: Mechanical Ventilation; Smoking; Intensive Care

Treatments: Drug: Nicotine patch; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01104896

NICOREA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Nicotine

Active Comparator group

Description:

One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale.

Treatment:

Drug: Nicotine patch

Placebo

Placebo Comparator group

Description:

One or two patch(es) with placebo

Treatment:

Drug: Placebo