Status:
ACTIVE_NOT_RECRUITING
SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Covid19
Hypoxic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, will need life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sl...
Detailed Description
Multicentre open-label, pragmatic, randomized controlled trial and a parallel prospective (non-randomized) cohort study conducted in ICUs and ICU enabled environments caring in critically ill COVID-19...
Eligibility Criteria
Inclusion
- ≥ 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.
- Mechanically ventilated patients +/- extracorporeal membrane oxygenation (extracorporeal life) support with:
- Proven or suspected (under investigation) COVID-19, or
- 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
- 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04415060
Start Date
June 15 2020
End Date
June 15 2027
Last Update
July 22 2025
Active Locations (13)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
3
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
4
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada