Inhaled sedation versus intravenous sedation in critically ill patients (IS-CRITIC): protocol for a multicentre, randomised, controlled clinical trial in Spain
16 affiliations
- 1Department of Critical Care Medicine, Hospital Universitario La Paz, Madrid, Spain
- 2Instituto de Investigación del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain
- 3CIBER de Enfermedades Respiratorias (CIBERES). Instituto de Salud Carlos III, Madrid, Spain
- 4Department of Critical Care Medicine, Hospital Universitario Doctor Jose Molina Orosa, Arrecife, Spain
- 5Department of Critical Care Medicine, Hospital Universitario Infanta Leonor, Madrid, Spain
- 6Department of Critical Care Medicine, Hospital General Universitario Gregorio Marañón, Madrid, Spain
- 7Department of Critical Care Medicine, Hospital Universitario Rey Juan Carlos, Móstoles, Madrid, Spain
- 8Department of Critical Care Medicine, Hospital Universitario de la Princesa, Madrid, Spain
- 9Department of Critical Care Medicine, Hospital Universitario Río Hortega, Valladolid, Spain
- 10Department of Critical Care Medicine, Hospital Vall d’Hebron, Barcelona, Spain
- 11Department of Critical Care Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Spain
- 12Department of Critical Care Medicine, Hospital Clinico Universitario de Valencia, Valencia, Spain
- 13Department of Critical Care Medicine, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain
- 14Department of Clinical Pharmacology, Hospital Universitario La Paz, Madrid, Spain
- 15Universidad Autónoma de Madrid, Madrid, Spain
- 16Data Unit, Hospital Universitario La Paz, Madrid, Spain
Abstract
Introduction Intravenous sedatives are widely used in the intensive care unit (ICU) and are part of routine clinical practice. However, these agents and their active metabolites may be associated with adverse events. Volatile anaesthetics have recently emerged as an attractive alternative for ICU sedation, and isoflurane has been approved by regulatory agencies in several European countries for use in critically ill patients. Although isoflurane has been shown to be non-inferior to propofol-based sedation during short-term sedation periods, it remains unclear whether inhaled sedation with isoflurane offers advantages over intravenous sedation in patients requiring prolonged mechanical ventilation and, consequently, prolonged sedation.Methods and analysis This is a phase IV, low-intervention, open-label, multicentre randomised clinical trial conducted on an intention-to-treat basis. A total of 620 patients will be randomised in a 1:1 ratio to receive either inhaled sedation with isoflurane administered using the Sedaconda ACD-S device or intravenous sedation with propofol. Adult patients expected to require more than 48 hours of mechanical ventilation will be included. The primary outcome is ventilator-free days through day 28 post-randomisation. The key secondary outcome is ICU-free days through day 28 post-randomisation. Patient recruitment began in December 2025 and is expected to conclude in December 2027. Final analysis is planned for 2028.Ethics and dissemination The study protocol was approved by the ethics committee of Hospital Universitario La Paz, Madrid, Spain (#6844) and the European Medicines Agency on 13 March 2025. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT07000526.This clinical trial is registered in the European Union (EU) Clinical Trials Information System (CTIS), under the EU Clinical Trials Regulation (Regulation 536/2014). CTIS ID: (2024–5 18 521-14-00).
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BibTeX
@article{anon2026inhaled,
title = {{Inhaled sedation versus intravenous sedation in critically ill patients (IS-CRITIC): protocol for a multicentre, randomised, controlled clinical trial in Spain}},
author = {José Manuel Añón and Andoni García-Muñoz and María Paz Escuela and José Manuel Gómez-García and Manuel Pérez Torres and Arís Pérez- Lucendo and Ana María Prieto and Sofía Contreras and Eva Benveniste and Mónica García-Simón and Oriol Plans-Galván and Eugenia Graciani-Cantisan and Covadonga Rodríguez-Ruiz and Alexander Agrifoglio and Gloria Gonzalo and Laura Macaya and Begoña Bueno and Arturo Rodríguez-Pérez and Marta Martín-Muñoz and Sara Alcántara and Rocío Prieto-Pérez and Mariana Díaz Almirón},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-123745},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123745},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Inhaled sedation versus intravenous sedation in critically ill patients (IS-CRITIC): protocol for a multicentre, randomised, controlled clinical trial in Spain
AU - José Manuel Añón
AU - Andoni García-Muñoz
AU - María Paz Escuela
AU - José Manuel Gómez-García
AU - Manuel Pérez Torres
AU - Arís Pérez- Lucendo
AU - Ana María Prieto
AU - Sofía Contreras
AU - Eva Benveniste
AU - Mónica García-Simón
AU - Oriol Plans-Galván
AU - Eugenia Graciani-Cantisan
AU - Covadonga Rodríguez-Ruiz
AU - Alexander Agrifoglio
AU - Gloria Gonzalo
AU - Laura Macaya
AU - Begoña Bueno
AU - Arturo Rodríguez-Pérez
AU - Marta Martín-Muñoz
AU - Sara Alcántara
AU - Rocío Prieto-Pérez
AU - Mariana Díaz Almirón
PY - 2026
DA - 2026/10/23
JO - BMJ Open
DO - 10.1136/bmjopen-2026-123745
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123745
AB - Introduction Intravenous sedatives are widely used in the intensive care unit (ICU) and are part of routine clinical practice. However, these agents and their active metabolites may be associated with adverse events. Volatile anaesthetics have recently emerged as an attractive alternative for ICU sedation, and isoflurane has been approved by regulatory agencies in several European countries for use in critically ill patients. Although isoflurane has been shown to be non-inferior to propofol-based sedation during short-term sedation periods, it remains unclear whether inhaled sedation with isoflurane offers advantages over intravenous sedation in patients requiring prolonged mechanical ventilation and, consequently, prolonged sedation.Methods and analysis This is a phase IV, low-intervention, open-label, multicentre randomised clinical trial conducted on an intention-to-treat basis. A total of 620 patients will be randomised in a 1:1 ratio to receive either inhaled sedation with isoflurane administered using the Sedaconda ACD-S device or intravenous sedation with propofol. Adult patients expected to require more than 48 hours of mechanical ventilation will be included. The primary outcome is ventilator-free days through day 28 post-randomisation. The key secondary outcome is ICU-free days through day 28 post-randomisation. Patient recruitment began in December 2025 and is expected to conclude in December 2027. Final analysis is planned for 2028.Ethics and dissemination The study protocol was approved by the ethics committee of Hospital Universitario La Paz, Madrid, Spain (#6844) and the European Medicines Agency on 13 March 2025. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT07000526.This clinical trial is registered in the European Union (EU) Clinical Trials Information System (CTIS), under the EU Clinical Trials Regulation (Regulation 536/2014). CTIS ID: (2024–5 18 521-14-00).
SN - 2044-6055
SN - 2044-6055
ER -