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

Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit

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.

Study Overview

• Status: Unknown
• Conditions: Smoking; Intensive Care; Mechanical Ventilation
• Intervention / Treatment: Drug: Nicotine patch; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shohreh Azimi; Phone Number: +33 1 44 84 17 79; Email: shohreh.azimi@sls.aphp.fr

Study Locations

• France
  • Paris, France, 75908
    • Recruiting
    • Hegp-Aphp
    • Contact: Didier Journois, M.D. Ph.D.; Phone Number: +33 1 56 09 33 40; Email: d.journois@invivo.edu
    • Principal Investigator: Didier Journois, M.D. Ph.D.
    • Sub-Investigator: Florence Bellenfant, M.D.
    • Sub-Investigator: Alain Guinvarch, M.D.
    • Sub-Investigator: Talna Kortchinsky, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nicotine; One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale.	Drug: Nicotine patch; One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days; Other Names: Nicorette
PLACEBO_COMPARATOR: Placebo; One or two patch(es) with placebo	Drug: Placebo; One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days; Other Names: Nicorette placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Paris 5 - Rene Descartes
• Collaborators: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Didier Journois, M.D. Ph.D., AP-HP, Université René Descartes

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): February 1, 2012
• Study Completion (ANTICIPATED): February 1, 2012

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (ESTIMATE): April 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 16, 2010
• Last Update Submitted That Met QC Criteria: April 14, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: mechanical ventilation; tobacco; nicotine; Cigarette
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICOREA