Overview

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

Status:
Unknown status
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Paris 5 - Rene Descartes
Collaborator:
Assistance Publique - Hôpitaux de Paris
Treatments:
Nicotine
Criteria
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