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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05381818
Eligibility Criteria:
Inclusion Criteria:
* 18 or older
* History of current or previous tobacco use (including vaping containing nicotine products)
* One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex.
* History of smoking related lung disease
* Projected surgical time \> 30 minutes
* Ability to follow instructions to complete IMT exercises
* Ability to communicate adverse effects such as pain or fatigue or the need for assistance
Exclusion Criteria:
* American Society of Anesthesiologists physical status classification of 4 or greater .
* Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication,
* Preoperative dependence on continuous supplemental oxygen dependence.
* Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted),
* Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke),
* Participating in a pulmonary rehabilitation program
* Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1\<50% predicted.
* Patients with an infectious disease requiring isolation (i.e. COVID-19).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05381818
Study Brief:
Protocol Section:
NCT05381818