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

NCT01104896 | Unknown Phase 4 DMC

• 1 other identifier: NICOREA
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Mechanical Ventilation; Intensive Care

Keywords

Cigarette; tobacco; mechanical ventilation; nicotine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Nicotine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

One or two patch(es) with placebo

Drug: Placebo

Interventions

Nicotine patch DRUG

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

Also known as: Nicorette

Nicotine

Placebo DRUG

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

Also known as: Nicorette placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Paris 5 - Rene Descartes: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Hegp-Aphp

Paris, France, 75908, France

RECRUITING

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Didier Journois, M.D. Ph.D.

  AP-HP, Université René Descartes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shohreh Azimi

CONTACT

+33 1 44 84 17 79; shohreh.azimi@sls.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 16, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 16, 2010

Record last verified: 2010-04

Locations

FR (1)