Outcome of nicotine replacement therapy in the patients admitted to Intensive Care Unit
| ISRCTN | ISRCTN66928309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66928309 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/06/2010
- Registration date
- 10/08/2010
- Last edited
- 15/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Stumacher
Scientific
Scientific
St. Barnabas Hospital
4422, Third Avenue
Bronx, New York
10457
United States of America
Study information
| Study design | Randomised case-control double blinded prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Outcome of nicotine replacement therapy in the patients admitted to Intensive Care Unit: a randomised case-control double blinded prospective trial |
| Study objectives | Nicotine replacement therapy decreases the length of Intensive Care Unit (ICU) stay and increases ventilator free days in intubated patients. |
| Ethics approval(s) | Independent Institutional Review Board (chaired by Dr. Joseph Chang, M.D) approved on the 1st December 2009 (ref: 2009.23) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nicotine replacement therapy |
| Primary outcome measure | 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 study start date | 01/01/2009 |
| Completion date | 30/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 30/07/2009 |
Locations
Countries of recruitment
- United States of America
Study participating centre
St. Barnabas Hospital
Bronx, New York
10457
United States of America
10457
United States of America
Sponsor information
St Barnabas Hospital (USA)
Hospital/treatment centre
Hospital/treatment centre
4422, Third Avenue
Bronx, NY
10457
United States of America
| Website | http://www.stbarnabashospital.org/ |
|---|---|
"ROR" |
https://ror.org/02952et24 |
Funders
Funder type
Other
Investigator initiated and funded (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No |
