Condition category
Mental and Behavioural Disorders
Date applied
30/06/2010
Date assigned
10/08/2010
Last edited
15/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Stumacher

ORCID ID

Contact details

St. Barnabas Hospital
4422
Third Avenue
Bronx
New York
10457
United States of America

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

http://www.stbarnabashospital.org/

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

  1. 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.

Additional files

Editorial Notes