SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival (SAVE-ICU)

This is an interventional treatment trial for Covid19 focused on measuring sedation, ICU, volatile anesthetics Read More

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. a) Proven or suspected (under investigation) COVID-19, or b) 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.

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