SmokingPhase 4NICOREANCT01104896
Effect of Daily Nicotine Patch Application on Mechanical Ventilation Weaning in Smoking Patients
A Phase 4 study testing Nicotine patch in people with Smoking and Mechanical Ventilation, run by University of Paris 5 - Rene Descartes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smoking, Mechanical Ventilation, Intensive Care
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hegp-Aphp
Paris, France, 75908
Didier Journois, M.D. Ph.D., +33 1 56 09 33 40, d.journois@invivo.edu
Didier Journois, M.D. Ph.D.
About this study
Official title: Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit
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.
Read the 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
- Being tested
- Nicotine patch, Placebo
- Keywords
- Cigarette, tobacco, mechanical ventilation, nicotine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicorette
One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days
PlaceboDrug
Also called Nicorette placebo
One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nicotine patch |
| Placebo | Placebo comparator | One or two patch(es) with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of mechanical ventilation expressed in hours
Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours
Measured: 48 hours after extubation
Secondary outcomes (10)
Length of stay in the ICU expressed in day(s)
Measured: Within the first 30 days
Number of failure of mechanical ventilation weaning
Measured: Within the first 30 days
Incidence of score above +1 of the RASS scale measured every 4 hours
Measured: Within the first 30 days
Number of days with delirium assessed by the CAM-ICU score
Measured: 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
Measured: Within the first 30 days
Number of self-extubation(s)
Measured: Within the first 30 days
Number of pneumonia acquired during mechanical ventilation
Measured: Within the first 30 days
SOFA score
Measured: between 48 and 72 hrs
Tobacco weaning rate at hospital discharge
Measured: Within the first 120 days
28th day mortality rate
Measured: betwwen 28th and 48th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Investigators
- Didier Journois, M.D. Ph.D., Principal investigator, AP-HP, Université René Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104896
- Sponsor's protocol ID
- NICOREA
- Acronym
- NICOREA
- Status last verified
- Apr 2010
- First submitted
- 12 Apr 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01104896
- Acronym / sponsor ID
- NICOREA / NICOREA
- Conditions
- Smoking, Mechanical Ventilation, Intensive Care
- Keywords
- Cigarette, tobacco, mechanical ventilation, nicotine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Jan 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine | Active comparator | Drug: Nicotine patchOne or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale. |
| Placebo | Placebo comparator | Drug: PlaceboOne or two patch(es) with placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchAlso: NicoretteOne or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days | Drug | Nicotine |
| PlaceboAlso: Nicorette placeboOne or two placebo patch(es) applied from 6am to 10 pm each day for 21 days | Drug | Placebo |
Primary outcome
Length of mechanical ventilation expressed in hours
Time frame: 48 hours after extubation
Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours
10 secondary outcomes
Length of stay in the ICU expressed in day(s)
Time frame: Within the first 30 days
Number of failure of mechanical ventilation weaning
Time frame: Within the first 30 days
Incidence of score above +1 of the RASS scale measured every 4 hours
Time frame: Within the first 30 days
Number of days with delirium assessed by the CAM-ICU score
Time frame: 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
Time frame: Within the first 30 days
Number of self-extubation(s)
Time frame: Within the first 30 days
Number of pneumonia acquired during mechanical ventilation
Time frame: Within the first 30 days
SOFA score
Time frame: between 48 and 72 hrs
Tobacco weaning rate at hospital discharge
Time frame: Within the first 120 days
28th day mortality rate
Time frame: betwwen 28th and 48th days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Journois, M.D. Ph.D. principal investigator
AP-HP, Université René Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch in people with Smoking and Mechanical Ventilation, run by University of Paris 5 - Rene Descartes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shohreh Azimi (+33 1 44 84 17 79, shohreh.azimi@sls.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of mechanical ventilation expressed in hours (time frame: 48 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2010.