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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jun 2, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of different sedation methods on patients with severe breathing problems, particularly those related to COVID-19. When patients are on a breathing machine, they often need medication to keep them comfortable and asleep. Due to high demand, some of the usual sedation drugs are in short supply. This study will compare traditional intravenous sedation with inhaled sedation gases, which are more readily available. The goal is to see if inhaled agents can help patients recover faster, spend less time on the breathing machine, and ultimately improve survival rates.

To participate in this trial, patients must be at least 18 years old, currently on a breathing machine, and expected to remain on it for at least another day. They must also have proven or suspected COVID-19 or specific breathing difficulties. Participants can expect to be closely monitored by a team of experts as they receive either the traditional or inhaled sedation. The findings from this research could help improve care for critically ill patients and make better use of available resources in hospitals.

Gender

ALL

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