Clinical Research Directory

Inhaled Sedation in Critically Ill Patients

The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol. The primary endpoint is the number of ventilator-free days at 28 days after randomization.

The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial

The METEOR Trial will compare four implementation strategies-traditional online education, protocol-directed care, interprofessional education, and a combination of protocol-directed care and interprofessional education-to test the hypotheses that interprofessional education is superior to traditional online education as an implementation strategy in the intensive care unit (ICU) and the benefits of interprofessional education are increased when interprofessional education is paired with a clinical protocol. Additionally, the trial will also test the hypothesis that preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients are both superior to current clinical practice (i.e., conventional post-extubation oxygen therapy).

One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial

This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on pressure support. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions:1) One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.2) Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.

One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial

This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on T-piece. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions: 1. One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated. 2. Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.

Site of Tracheal Extubation and Operating Room Efficiency During Robot-assisted Surgery

This study aims to evaluate the impact of different extubation strategy on the occupancy time of operating room (OR) and the incidence of adverse events and quality of recovery after robotic-assisted surgery. The investigators hypothesize that extubation in the post-anesthesia care unit (PACU) may reduce OR occupancy time without increasing adverse events or worsening quality of recovery early after robotic-assisted surgery. This strategy may enhance perioperative efficiency while maintaining clinical safety.

Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support

Timely and safe extubation in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient's readiness for extubation. However, SBTs are performed in various ways and have poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making. In a prior multicenter study, the investigators showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices. The Extubation Advisor (EA) tool combines clinician's assessments of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study, the investigators demonstrated the ability to deliver EA reports to the bedside and acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs). The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes. They will include critically ill adults who are invasively ventilated for \>48 hours and are ready to undergo an SBT. Patients in the intervention arm undergo an EA assessment and treating clinicians (RTs, MDs) will receive an EA report for each SBT conducted. The EA report will help to guide extubation decision-making. Patients in the control arm receive standard care. SBTs will be directed by clinicians. The primary feasibility outcome will reflect the ability to recruit the desired population. The investigators will also assess the usefulness of the tool to MDs and complete an analysis of resource utilization to inform future economic analyses of cost-effectiveness. The investigators aim to recruit 1 to 2 patients/month/center. The LEADS trial is novel and low-risk. It is the first trial to evaluate use of a bedside decision support tool to assist ICU clinicians with extubation decision-making. The LEADS pilot trial will inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in ICUs.