COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04415060

Angela Jerath, MD

angela.jerath@sunnybrook.ca

2020-06-04

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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. 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.

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

2

Sunnybrook Health Sciences Centre

18

100

Canada

Critical disease at enrollment

8: Critical disease at enrollment

758

Hospital Mortality;Ventilator-Free Days;Participant Quality of Life at 3 and 12 months after discharge;ICU-Free Days

None

Phase 3

[{"arm_notes": "There will be variable randomized ratios of 2:1 or 1:2 to either an intravenous based sedation arm or an inhaled volatile-based sedation arm", "treatment_id": 1189, "treatment_name": "Sevoflurane or isoflurane", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]