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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Paris 5 - Rene Descartes.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Paris 5 - Rene Descartes
ClinicalTrials.gov Identifier:
NCT01104896
First received: April 12, 2010
Last updated: April 14, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Smoking
Mechanical Ventilation
Intensive Care
Drug: Nicotine patch
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Paris 5 - Rene Descartes:

Primary Outcome Measures:
  • Length of mechanical ventilation expressed in hours [ Time Frame: 48 hours after extubation ] [ Designated as safety issue: No ]
    Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours


Secondary Outcome Measures:
  • Length of stay in the ICU expressed in day(s) [ Time Frame: Within the first 30 days ] [ Designated as safety issue: No ]
  • Number of failure of mechanical ventilation weaning [ Time Frame: Within the first 30 days ] [ Designated as safety issue: No ]
  • Incidence of score above +1 of the RASS scale measured every 4 hours [ Time Frame: Within the first 30 days ] [ Designated as safety issue: No ]
  • Number of days with delirium assessed by the CAM-ICU score [ Time Frame: Within the first 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of self-extubation(s) [ Time Frame: Within the first 30 days ] [ Designated as safety issue: Yes ]
  • Number of pneumonia acquired during mechanical ventilation [ Time Frame: Within the first 30 days ] [ Designated as safety issue: No ]
  • SOFA score [ Time Frame: between 48 and 72 hrs ] [ Designated as safety issue: No ]
  • Tobacco weaning rate at hospital discharge [ Time Frame: Within the first 120 days ] [ Designated as safety issue: No ]
  • 28th day mortality rate [ Time Frame: betwwen 28th and 48th days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104896

Contacts
Contact: Shohreh Azimi +33 1 44 84 17 79 shohreh.azimi@sls.aphp.fr

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

Additional Information:
No publications provided

Responsible Party: Pr Didier Journois, AP-HP, Université René Descartes
ClinicalTrials.gov Identifier: NCT01104896     History of Changes
Other Study ID Numbers: NICOREA
Study First Received: April 12, 2010
Last Updated: April 14, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Paris 5 - Rene Descartes:
Cigarette
tobacco
mechanical ventilation
nicotine

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014