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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT02958150
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years of age.
* Competent or with legal representative able to sign inform consent.
* Reversible ARF secondary to heart failure, COPD exacerbation, pneumonia, or at risk of pot-extubation failure\* who meet the criteria for starting NIV.
* Signs and symptoms of respiratory distress or
* Moderate to severe dyspnoea, grater than usual and/or
* Respiratory rate greater than 25 in COPD or greater than 30 in hypoxemic ARF and/or
* Use of accessory muscles and/or paradoxical breathing and/or
* Hypercapnic encephalopathy
* And changes in gas exchange
* PaCO2\>45 mmHg, pH\<7.35 and/or
* PaO2/FiO2 between 300 and 150.
\*Patients at risk of post-extubation failure: Patients who meet at least one of the following criteria.
* Impaired consciousness.
* Age over 65 years
* Heart failure with EF \>30%
* Severe disease with an Acute Physiology and Chronic Health Evaluation (APSCHE) score \>12.
* Protracted weaning before extubation
Exclusion Criteria:
* Respiratory arrest, direct indication of OTI and IMV.
* Severe unstable comorbidity (myocardial ischemia with ejection fraction \<30%, arrythmia, uncontrolled hypotension defined as systolic blood pressure less than 90 mmHg with doses of norepinephrine\>0.5 mcg/kg/min and/or dobutamine\>10 mcg/kg/min).
* Inability to protect the airway: bronchial aspiration.
* Fixed upper airway obstruction.
* Tracheostomy.
* Undrained pneumothorax.
* Severe agitation or lack of collaboration of the patient despite medication administered.
* Facial burns or trauma.
* Facial surgery or anatomical changes which prevent mask fitting.
* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
* Allergy to eggs, soya, or peanuts.
* HR\< 50 bpm not induced by beta- blockers.
* Advanced heart block (grade 2 or 3) unless paced.
* Acute cerebrovascular conditions.
* Increased intracranial pressure.
* Closed angle glaucoma.
* Myasthenia gravis.
* Concurrent use of CYP3A4 inhibitors (amprenavir, atazanavir, or ritonavir).
* Refuse to participate in the trial.
* Pregnant or nursing patients.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02958150
Study Brief:
Protocol Section:
NCT02958150