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Studies

Interventional Recruiting Phase 4

NCT07000526 on ClinicalTrials.gov

Inhaled Sedation in Critically Ill Patients

Official title: Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial

  • Sponsor: Hospital La Paz Institute for Health Research
  • Collaborators: Instituto de Salud Carlos III
  • Enrollment: 620 (Estimated)
  • Study start: 2025-12-15 (Actual)
  • Primary completion: 2027-03-01 (Estimated)
  • Study completion: 2027-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Sedation
  • Airway Extubation

Intervention / Treatment

  • Drug: Isoflurane
  • Drug: Propofol

Primary Outcome Measures

  • Ventilator-free days at day 28 from randomization (From randomization until day 28)
    Number of days between randomization and day 28 during which the patient is alive and free from invasive mechanical ventilation. Patients who die before day 28, or who remain on mechanical ventilation at day 28, are assigned zero ventilator-free days.

Countries

Spain

Locations and Investigators

  • Hospital Vega Baja, Orihuela, Spain (Recruiting)
    • Carola Gimenez-Esparza, MD
    • Carola Gimenez-Esparza, MD (Principal Investigator)
  • Hospital Universitario Doctor José Molina Orosa, Arrecife, Spain (Not yet recruiting)
    • Andoni García-Muñoz, MD
    • Andoni García-Muñoz, MD (Principal Investigator)
  • Hospital Galdakao-Usansolo Ospitalea, Galdakao, Spain (Not yet recruiting)
    • Iraia Arbelaiz, MD
    • Iraia Arbelaiz, MD (Principal Investigator)
  • Hospital Universitario de Albacete, Albacete, Spain (Not yet recruiting)
    • Jose M. Gutierrez
    • José M. Gutierrez, MD (Principal Investigator)
  • Hospital Germans Trias i Pujol, Badalona, Spain (Recruiting)
    • Paula Pedreira
    • Paula Pedreira, MD (Principal Investigator)
  • Hospital Universitario de Bellvitge, Barcelona, Spain (Recruiting)
    • Paola Cardenas
    • Paola Cardenas, MD (Principal Investigator)
  • Hospital Universitario Valle de Hebron, Barcelona, Spain (Recruiting)
    • Raquel S. Contreras, MD
    • Raquel S. Contreras, MD (Principal Investigator)
  • Hospital Universitario de Jaen, Jaén, Spain (Not yet recruiting)
    • Miguel A Fernández-Sacristan, MD
    • Miguel A Fernández-Sacristan, MD (Principal Investigator)
  • Hospital Arnau de Vilanova, Lleida, Spain (Not yet recruiting)
    • Jesús Caballero, MD, PhD
    • Jesús Caballero, MD, PhD (Principal Investigator)
  • Hospital Universitario de Fuenlabrada, Madrid, Spain (Not yet recruiting)
    • Carmen C Sena-Pérez, MD
    • Carmen C Sena-Pérez, MD (Principal Investigator)
  • Hospital Universitario La Paz, Madrid, Spain (Recruiting)
  • Hospital Universitario Ramon y Cajal, Madrid, Spain (Not yet recruiting)
    • José Antonio Marquez, MD
    • José Antonio Marquez, MD (Principal Investigator)
  • Hospital Univeritario Puerta de Hierro, Madrid, Spain (Not yet recruiting)
    • Miguel Angel Romera, MD,PhD
    • Miguel Angel Romera, MD (Principal Investigator)
  • Hospital Universitario de la Princesa, Madrid, Spain (Recruiting)
    • Aris Perez Lucendo, MD
    • Aris Perez Lucendo, MD (Principal Investigator)
  • Hospital Universitario Gregorio Marañon, Madrid, Spain (Recruiting)
    • José M. Gomez, MD
    • José M. Gomez, MD (Principal Investigator)
  • Hospital Universitario Infanta Leonor, Madrid, Spain (Recruiting)
    • María Paz Escuela, MD, PhD
    • María Paz Escuela, MD, PhD (Principal Investigator)
  • Hospital Universitario Rey Juan Carlos, Madrid, Spain (Recruiting)
    • Manuel Pérez Torres
    • Manuel Perez Torres, MD (Principal Investigator)
  • Hospital Regional Universitario de Málaga, Málaga, Spain (Not yet recruiting)
    • Guillermo Gomez, MD
    • Guillermo Gomez, MD (Principal Investigator)
  • Hospital Universitario Joan XXIII, Tarragona, Spain (Recruiting)
    • Oriol Plans
    • Oriol Plans, MD (Principal Investigator)
  • Hospital Universitario de Toledo, Toledo, Spain (Not yet recruiting)
    • Mario Dalorzo
    • Mario Dalorzo, MD (Principal Investigator)
  • Hospital Clínico Universitario de Valencia, Valencia, Spain (Recruiting)
    • Monica García Simon, MD
    • Monica García Simón, MD (Principal Investigator)
  • Hospital Universitario Rio Hortega, Valladolid, Spain (Recruiting)
    • Ana Prieto
    • Ana Prieto, MD (Principal Investigator)

Study Officials