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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104896
Recruitment Status : Unknown
Verified April 2010 by University of Paris 5 - Rene Descartes.
Recruitment status was:  Recruiting
First Posted : April 16, 2010
Last Update Posted : April 16, 2010
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Paris 5 - Rene Descartes

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.

Condition or disease Intervention/treatment Phase
Smoking Mechanical Ventilation Intensive Care Drug: Nicotine patch Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit
Study Start Date : January 2010
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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 Name: 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 Name: Nicorette placebo

Primary Outcome Measures :
  1. Length of mechanical ventilation expressed in hours [ Time Frame: 48 hours after extubation ]
    Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours

Secondary Outcome Measures :
  1. Length of stay in the ICU expressed in day(s) [ Time Frame: Within the first 30 days ]
  2. Number of failure of mechanical ventilation weaning [ Time Frame: Within the first 30 days ]
  3. Incidence of score above +1 of the RASS scale measured every 4 hours [ Time Frame: Within the first 30 days ]
  4. Number of days with delirium assessed by the CAM-ICU score [ Time Frame: Within the first 30 days ]
  5. Number of hours under sedation below RASS -4, between -3,-2, -2,+1 indexed by the overall duration of sedation [ Time Frame: Within the first 30 days ]
  6. Number of self-extubation(s) [ Time Frame: Within the first 30 days ]
  7. Number of pneumonia acquired during mechanical ventilation [ Time Frame: Within the first 30 days ]
  8. SOFA score [ Time Frame: between 48 and 72 hrs ]
  9. Tobacco weaning rate at hospital discharge [ Time Frame: Within the first 120 days ]
  10. 28th day mortality rate [ Time Frame: betwwen 28th and 48th days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01104896

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Contact: Shohreh Azimi +33 1 44 84 17 79

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Hegp-Aphp Recruiting
Paris, France, 75908
Contact: Didier Journois, M.D. Ph.D.    +33 1 56 09 33 40   
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.         
Sponsors and Collaborators
University of Paris 5 - Rene Descartes
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Didier Journois, M.D. Ph.D. AP-HP, Université René Descartes

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Responsible Party: Pr Didier Journois, AP-HP, Université René Descartes Identifier: NCT01104896     History of Changes
Other Study ID Numbers: NICOREA
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: April 16, 2010
Last Verified: April 2010
Keywords provided by University of Paris 5 - Rene Descartes:
mechanical ventilation
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action