Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Outcome of nicotine replacement therapy in the patients admitted to Intensive Care Unit: a randomised case-control double blinded prospective trial
Acronym
Study hypothesis
Nicotine replacement therapy decreases the length of Intensive Care Unit (ICU) stay and increases ventilator free days in intubated patients.
Ethics approval
Independent Institutional Review Board (chaired by Dr. Joseph Chang, M.D) approved on the 1st December 2009 (ref: 2009.23)
Study design
Randomised case-control double blinded prospective trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking cessation
Intervention
Interventional arm:
After randomising patients into case and control, we applied nicotine patch containing nicotine 21 mg on the skin for patients who were cases. We applied it every day until patient was discharged from the ICU, transferred to General medical floor or until 10 weeks (if the patient was in ICU for 10 weeks).
Control arm:
For the control group the frequency and the duration was same but the patch did not contain nicotine.
Patients were unaware if they had nicotine patch or placebo patch. Patches were applied within 24 - 48 hours of ICU admission. Twenty four hours after the application of patch data was collected. The data collection researcher did not know which patient had nicotine patch and which patient had placebo. Patient was only followed up until the ICU stay.
Intervention type
Drug
Phase
Not Applicable
Drug names
Nicotine replacement therapy
Primary outcome measures
1. Decreased ICU stay, measured after the patient is out of ICU
2. Increased ventilator free days, measured when patient is breathing without the help of ventilator
Secondary outcome measures
Decreased use of sedation and analgesia, measured at the end of ICU stay
Overall trial start date
01/01/2009
Overall trial end date
30/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Smoker (greater than 1 pack per day [ppd] for greater than 1 year)
2. Admitted to ICU
3. Consent required either from patient or from surrogate
4. Aged greater than 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Pregnant
2. Myocardial infarction (MI) in last 2 weeks
3. Uncontrolled or serious arrhythmia
4. Severe allergic reaction to nicotine or patch
5. Peptic ulcer disease
6. Hyperthyroidism
Recruitment start date
01/01/2009
Recruitment end date
30/07/2009
Locations
Countries of recruitment
United States of America
Trial participating centre
St. Barnabas Hospital
Bronx, New York
10457
United States of America
Sponsor information
Organisation
St Barnabas Hospital (USA)
Sponsor details
4422
Third Avenue
Bronx
NY
10457
United States of America
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23533293
Publication citations
-
Results
Pathak V, Rendon IS, Lupu R, Tactuk N, Olutade T, Durham C, Stumacher R, Outcome of nicotine replacement therapy in patients admitted to ICU: a randomized controlled double-blind prospective pilot study., Respir Care, 2013, 58, 10, 1625-1629, doi: 10.4187/respcare.01791.