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

University of Paris 5 - Rene Descartes600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

600

Conditions

Smoking Mechanical Ventilation Intensive Care

Interventions

Nicotine patchDRUG

One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days

PlaceboDRUG

One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hegp-Aphp

Paris, France, France

RECRUITING

Outcomes

Primary Outcomes

Length of mechanical ventilation expressed in hours

Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours

Time frame: 48 hours after extubation