NCT01104896

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

Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Paris 5 - Rene Descartes · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking
• Mechanical Ventilation
• Intensive Care

Interventions

Type	Name	Description
DRUG	Nicotine patch	One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days
DRUG	Placebo	One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-04-16
• Last updated: 2010-04-16

Locations

1 site across 1 country: France