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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04315558
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 40 years of age
* Acute respiratory failure requiring invasive mechanical ventilation
* Documented history of COPD based on spirometric evidence of FEV1/FVC\<70%
* Smoking history \>10 years (current or prior)
* Invasive mechanical ventilation for \< 96 hours
Exclusion Criteria:
* Chronic invasive mechanical ventilation via tracheostomy. Patients with tracheostomy alone without chronic mechanical ventilation may be enrolled.
* Expected duration of mechanical ventilation \<24 hours
* Hypersensitivity to muscarinic antagonists
* Inability to tolerate albuterol
* Lack of documented COPD history
* For patients taking short- or long-acting muscarinic antagonists (SAMAs or LAMAs) at the time of screening, inability or unwillingness to undergo the SAMA or LAMA washout period (6 hours or 24 hours, respectively) prior to initiating study drug.
* Presence of ARDS or acute congestive heart failure
* Unwillingness or inability to remain on the study drug with for the duration of the study
* Unwillingness or inability to have open-label muscarinic antagonists withheld for duration of the study
* Unwillingness or inability to utilize the Puritan-Bennett 980 (PB980) ventilator
* Pulmonary comorbidities such as pneumothorax or pneumomediastinum that, in the opinion of the investigator or clinical team, can pose a risk to subject safety or interfere with the subject's ability to complete the study procedures.
* Documented restrictive lung disease or history of interstitial lung disease
* Actual body weight exceeding 1 kg per centimeter of height
* Pregnancy
* AST or ALT \> 3 times the upper limit of normal, or other clinically significant acute or chronic liver disease
* Known history of glaucoma
* Enrollment in other interventional clinical trial
* Moribund patient not expected to survive \>24 hours
* Decision to withhold life-sustaining treatment, except in those patients committed to full support except cardiopulmonary resuscitation
* Inability to obtain informed consent from patient or legally authorized representative (LAR)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04315558
Study Brief:
Protocol Section:
NCT04315558