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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    752
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 27 January 2021
critical illness

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 sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs given through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines.

Another way to provide sleep is by using gases that are breathed in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies.

This research is a study being carried out in a number of hospitals that will compare how well patients recover from these illnesses depending on which type of sedation drug they receive. The plan is to evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Finally, this trial will be a team of experts in sedation drugs who care for patients with proven or suspected COVID-19 who need lifesaving treatments.

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 patients.

Participants will be adults who are mechanically ventilated with proven or suspected COVID-19 disease or suffering from hypoxic lung failure. All centres will be required to randomize every available patient, as non-randomized participants can be entered into a parallel prospective cohort study to try to obtain the maximum amount of information available from the patients present to our ICUs.

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. This randomization will be dependent on availability of sedative drugs for both arms. Patients who cannot be randomized (secondary to technical or resource issues in some areas of the hospital) will receive intravenous or inhaled sedation as able in their designated unit. Sedation will be administered according to standard sedation practice and in keeping with current guidelines.

Participants will remain within their sedation arms until the primary care team decides to stop sedation. Participants will be followed daily throughout their ICU stay for 30 days after enrollment and then at death or hospital discharge (whichever occurs first).

Clinical information during ICU stay will be obtained from the patient chart, electronic medical records, or hospital databases. Participants will be followed using a provincial or hospital healthcare database to obtain survival, and hospital-free days at 60 days, 90 days and 365 days after enrollment.

After hospital discharge, participants will be followed up at; 3 and 12 months to assess quality of life using the EQ-5D; and to assess disability using the WHODAS 2.0.

Details
Condition COVID19
Treatment Sevoflurane Inhalant Product, Isoflurane Inhalant Product
Clinical Study IdentifierNCT04415060
SponsorSunnybrook Health Sciences Centre
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have COVID19?
Do you have any of these conditions: Do you have COVID19??
Do you have any of these conditions: Do you have COVID19??
Do you have any of these conditions: Do you have COVID19??
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. 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
One-lung ventilation or pneumonectomy
Ideal estimated tidal volume too low for delivery of inhaled agents. Target (6ml/kg) < 200ml
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
Known pregnancy
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
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