Clinical trial NCT01104896: Effect of Daily Nicotine Patch Application on Mechanical Ventilation Weaning in Smoking Patients
Official title: Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Smoking
Mechanical Ventilation
Intensive Care
Keywords: Cigarette
tobacco
mechanical ventilation
nicotine
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2010-04-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Length of mechanical ventilation expressed in hours
timeFrame: 48 hours after extubation
Secondary outcomes:
measure: Length of stay in the ICU expressed in day(s)
timeFrame: Within the first 30 days
measure: Number of failure of mechanical ventilation weaning
timeFrame: Within the first 30 days
measure: Incidence of score above +1 of the RASS scale measured every 4 hours
timeFrame: Within the first 30 days
measure: Number of days with delirium assessed by the CAM-ICU score
timeFrame: Within the first 30 days
measure: Number of hours under sedation below RASS -4, between -3,-2, -2,+1 indexed by the overall duration of sedation
timeFrame: Within the first 30 days
measure: Number of self-extubation(s)
timeFrame: Within the first 30 days
measure: Number of pneumonia acquired during mechanical ventilation
timeFrame: Within the first 30 days
measure: SOFA score
timeFrame: between 48 and 72 hrs
measure: Tobacco weaning rate at hospital discharge
timeFrame: Within the first 120 days
measure: 28th day mortality rate
timeFrame: betwwen 28th and 48th days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hegp-Aphp
Study officials:
affiliation: AP-HP, Université René Descartes
name: Didier Journois, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: