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

NCT ID: NCT01104896

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-02-29

Brief 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.

Detailed 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.

Conditions

Smoking; Mechanical Ventilation; Intensive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Nicotine

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

Group Type: ACTIVE_COMPARATOR

Nicotine patch

Intervention Type: DRUG

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

Placebo

One or two patch(es) with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Nicotine patch

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Nicorette; Nicorette placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: lead

Responsible Party

AP-HP, Université René Descartes

Principal Investigators

Didier Journois, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Université René Descartes

Locations

Hegp-Aphp

Paris, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Shohreh Azimi

Role: CONTACT

shohreh.azimi@sls.aphp.fr

+33 1 44 84 17 79

Facility Contacts

Didier Journois, M.D. Ph.D.

Role: primary

d.journois@invivo.edu

+33 1 56 09 33 40

Other Identifiers

NICOREA

Identifier Type: -

Identifier Source: org_study_id