Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT01362959
Eligibility Criteria:
Inclusion Criteria: Any patient admitted to the intensive care unit must meet all of the following criteria to be eligible for the study:
* Critically ill active smoking patient
* Being mechanically ventilated
* Start of study product application within 48 hours after ICU admission
* Expected to be mechanically ventilated for more than 48 hours after start of application of the study product
Exclusion Criteria: Any patient admitted to the intensive care unit meeting one or more of the following criteria is not eligible for the study:
* Patient younger than 18 years
* Patient or next of kin denying research authorization
* Pregnancy
* Breastfeeding women
* History of chronic dementia or psychosis
* (Acute) neurologic disease on admission, possibly confounding study objectives (TBI, stroke, ICH/SAH, seizures, meningitis, encephalitis, intracranial tumor)
* Patient receiving any form of NRT within two weeks before admission
* Patient not understanding Dutch
* Patient with acute myocardial infarction
* Patient with severe cardiac arrhythmia
* Patient with unstable or deteriorating angina pectoris
* Patient with generalized acute or chronic skin diseases interfering with NRT absorption
* Patient with severe hearing deficiency
* Moribund patient
* Patient with known hypersensibility to nicotine or components of the transdermal therapeutic system
* Patient with known hypersensibility to patches
* Patient participating in an other study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01362959
Study Brief:
Protocol Section:
NCT01362959