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

Smoking Clinical Trial

— NICOREA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01104896
• Other study ID #: NICOREA
• Status: Recruiting
• Phase: Phase 4
• First received: April 12, 2010
• Last updated: April 14, 2010
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2010
• Source: University of Paris 5 - Rene Descartes
• Contact: Shohreh Azimi
• Phone: +33 1 44 84 17 79
• Email: shohreh.azimi[@]sls.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intensive Care
• Mechanical Ventilation
• Smoking

Intervention

Drug:
• Nicotine patch
One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days
• Placebo
One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days

Locations

Country	Name	City	State
France	Hegp-Aphp	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Length of stay in the ICU expressed in day(s)		Within the first 30 days	No
Secondary	Number of failure of mechanical ventilation weaning		Within the first 30 days	No
Secondary	Incidence of score above +1 of the RASS scale measured every 4 hours		Within the first 30 days	No
Secondary	Number of days with delirium assessed by the CAM-ICU score		Within the first 30 days	No
Secondary	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	No
Secondary	Number of self-extubation(s)		Within the first 30 days	Yes
Secondary	Number of pneumonia acquired during mechanical ventilation		Within the first 30 days	No
Secondary	SOFA score		between 48 and 72 hrs	No
Secondary	Tobacco weaning rate at hospital discharge		Within the first 120 days	No
Secondary	28th day mortality rate		betwwen 28th and 48th days	Yes