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

Phase 4

• Conditions: Smoking; Mechanical Ventilation; Intensive Care
• Interventions: Drug: Nicotine patch; Drug: Placebo

• Registration Number: NCT01104896
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-01
• Status Verified: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-14
• Last Update Submitted: 2010-04-14
• Study First Posted: 2010-04-16
• Last Update Posted: 2010-04-16
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine	Nicotine patch	One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale.
Placebo	Placebo	One or two patch(es) with placebo

Primary Outcome Measures

Name	Time	Method
Length of mechanical ventilation expressed in hours	48 hours after extubation	Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hegp-Aphp; 🇫🇷 Paris, France