SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival (SAVE-ICU)
Covid19, Hypoxic Respiratory Failure
About this trial
This is an interventional treatment trial for Covid19 focused on measuring sedation, ICU, volatile anesthetics
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age;
- Mechanically ventilated and expected to remain mechanically ventilated at the end of the next day;
- 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.
- 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:
- Contraindications to sedatives, such as propofol infusion syndrome or malignant hyperthermia;
- Known allergy to any of the ingredients or components of the investigational products; sevoflurane or isoflurane;
- Suspect or evidence of high intracranial pressure;
- Severe brain injury that is likely to lead to sustained very low conscious levels or vegetative state;
- Severe neuromuscular disorder for example amyotrophic lateral sclerosis, Gullian Barre Syndrome that are the primary cause of needing ICU admission and mechanical ventilation;
- One-lung ventilation or pneumonectomy;
- Ideal estimated tidal volume too low for delivery of inhaled agents. Target (6ml/kg) < 200ml;
- 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;
- Known pregnancy
- Moribund patient not expected to survive >12 hours
Sites / Locations
- University of Alberta HospitalRecruiting
- London Health Sciences Centre - University HospitalRecruiting
- London Health Sciences Centre - Victoria HospitalRecruiting
- The Ottawa HospitalRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- University Health Network - Toronto General HospitalRecruiting
- University Health Network - Toronto Western HopsitalRecruiting
- Centre Hospitalier de l'Université de MontréalRecruiting
- McGill University Health Centre - Royal Victoria HospitalRecruiting
- Hôpital Sacré-Coeur de MontréalRecruiting
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
- Universite de SherbrookeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
Inhaled - volatile anesthetic
Standard Care
Non-randomized
The ICU patient will be randomized to either Isoflurane or Sevoflurane, whichever is available at the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
The ICU patient will be randomized to standard of care, which is any IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
In this arm, ICU patients who cannot be randomized will receive inhaled or IV sedation as per available in their unit. This is done to try to obtain the maximum amount of information available from the patients present to our ICUs.