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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04415060
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years of age
2. Mechanically ventilated and expected to remain mechanically ventilated at the end of the next day
3. Receiving IV sedation by infusion or bolus for ≤72 hours to facilitate mechanical ventilation Transferred patients with escalating ventilation needs are eligible for recruitment within ≤72 hours of sedation commenced within the participating trial site that they were transferred to.
Note: Intravenous sedation required to support mechanical ventilation includes use of one or more of the following agents: benzodiazepines, propofol, ketamine, barbiturates, alpha-2 agonist, opioids. Patients receiving intravenous opioids only i.e., fentanyl ≥ 50mcg/hour, hydromorphone ≥ 0.4mg/hour (or bolus q1h) for analgesia and sedation or agitation to assist mechanical ventilation are eligible for inclusion.
4. Mechanically ventilated patients +/- extracorporeal membrane oxygenation (extracorporeal life) support with:
1. Proven or suspected (under investigation) COVID-19, or
2. COVID-19 negative patients who have a PaO2FiO2 ratio ≤300 measured with arterial blood gas at least once during the 12 hours prior to enrollment.
Note: If arterial blood gas measurement is unavailable, the PaO2 can be imputed from the pulse oximetry measurement
Exclusion Criteria:
1. Contraindications to sedatives, such as propofol infusion syndrome or malignant hyperthermia;
2. Known allergy to any of the ingredients or components of the investigational products; sevoflurane or isoflurane;
3. Suspect or evidence of high intracranial pressure;
4. Severe brain injury that is likely to lead to sustained very low conscious levels or vegetative state
5. Severe neuromuscular disorder for example amyotrophic lateral sclerosis, Gullian Barre Syndrome that are the primary cause of needing ICU admission and mechanical ventilation
6. One-lung ventilation or pneumonectomy;
7. Ideal estimated tidal volume too low for delivery of inhaled agents. Target (6ml/kg) \< 200ml;
8. Use of inhaled prostacyclin which is contraindicated in the presence of a miniature vaporizer (i.e., Anesthesia Conserving Device). This agent has a high viscosity that leads to poor vaporization of the volatile agent. Note: Other inhaled pulmonary vasodilators such as nitric oxide can be safely administered in the presence of miniature vaporizers. Use of prostacyclin is permissible with an anesthesia machine and MADM;
9. Known pregnancy
10. Moribund patient not expected to survive \>12 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04415060
Study Brief:
Protocol Section:
NCT04415060