A phase IV randomized, controlled, implementation trial of volatile based sedation in patients with COVID 19 (the ANACONDA study).
New Technology, Therapies, eHealth & mHealth
We aimed to conduct a controlled implementation trial during the COVID-19
pandemic of inhaled volatile based sedation across 3 sites (Sunnybrook, Toronto General and Toronto Western Hospitals) with recruitment of 50 patients. Key highlights:
1. Introduced real-time practice change at the bedside with no major safety concerns
2. Developed new care pathways, protocols, education tools, drug and equipment management systems
3. Created new tools for sedation care – an essential ICU therapy that can be adopted by other hospitals
4. Supported new education initiatives for the inter-disciplinary ICU team. Leaders from respiratory therapy, nursing and anesthesia assistant lead multi-disciplinary team education webinars at national meetings
5. Gained additional funding from CIHR and Ontario Government to study the efficacy of inhaled based sedation compared to traditional intravenous sedatives.
6. Supports 6 trainees and graduate students
Sedatives are essential agents that provide comfort for respiratory failure patients needing life-saving mechanical ventilation in intensive care units (ICU). Our study aimed to introduce a novel mode of inhaled volatile sedation therapy during the COVID-19 pandemic to tackle the worldwide intravenous (IV) sedative drug shortage. Inhaled volatile agents were in good supply and cheap. Importantly, volatile agents also possess potential therapeutic benefits for ventilated respiratory failure patients including (i) reducing systemic inflammation, and promoting faster awakening and extubation which can lead to more separation from a ventilator. In turn, this may assist better use of ICU resources (i.e., ventilators) and accelerate ICU and hospital discharge. Early data shows volatile agents offer good quality of sedation and safety profile. However, inhaled volatile sedation is a novel modality that introduces a new medication, delivery system and needs new clinical practices.
Methods: Pragmatic open-label pilot multicentre trial aimed to recruit 50 respiratory failure patients. 1:1 randomization to inhaled isoflurane sedation or IV sedation. A parallel non-randomized arm was included for few patients who could not be randomized given equipment shortages or lack of trained personnel.
Results: We implemented inhaled sedation across 3 hospitals and recruited 50 patients with no major adverse effects. Our pilot trial advanced into a CIHR and Ontario government funded national clinical trial (SAVE-ICU) across 16 hospitals. This large trial will evaluate whether inhaled sedatives improves a hierarchy of important patient and health system outcomes such as ICU-free-days, ventilator-free-days, quality of life, and mortality compared to IV agents. Further results will be reported upon trial completion.
Challenges: As inhaled sedation involves new agents, devices, team dynamics, we performed large-scale education of the multidisciplinary ICU team (MD, RNs, RTs, AAs).
1. Cuninghame S, Jerath A, Burry L, Orser B, Slessarev M et al. The effect of inhaled anesthestics on cognitive and psychiatric outcomes in critically ill adults: A systematic review and meta-analysis. Br J Anaesth. May 2023; In Press.
2. Jerath A, Slessarev M. The impact of the coronavirus pandemic on sedation in critical care. Curr Opin Crit Care. Feb 2023; 29(1):14-18. DOI: 10.1097/MCC.0000000000001011
3. Cuninghame S, Gorsky K, Francoeur C, Withington D, Burry L, Jerath A, Slessarev M. Effect of sedation with inhaled anaesthetics on cognitive and psychiatric outcomes in critically ill adults: a systematic review protocol. BMJ Open Feb 2022. 12(2): e052893; DOI: 10.1136/bmjopen-2021-052893.
4. Gorsky K, Cuningham S, Chen J, Jayaraj K, Withington D, Francoeur C, Slessarev M, Jerath A. Use of inhalational anaesthetic agents in paediatric and adult patients for status asthmaticus, status epilepticus and difficult sedation scenarios: a protocol for a systematic review. BMJ Open. Nov 2021; 11(11): e051745. DOI: 10.1136/bmjopen-2021-051745.
5. Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Inten Care Med. Aug 2020; 46(8); 1563-66. DOI: 10.1007/s00134-020-06154-8.
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