Inhaled Sedation in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Justification: Isoflurane has recently emerged as an attractive alternative for intensive care unit (ICU) sedation. Due to their favorable pharmaco-kinetic and dynamic profile, this agent has been progressively introduced into clinical practice. Isoflurane has proven to be non-inferior to propofol in terms of efficacy and safety and it has been suggested that it may facilitate ventilator weaning. However, no differences in length of mechanical ventilation were found. These studies have focused on short sedation durations. In fact, long-term effects and outcomes associated with isoflurane for ICU sedation are not yet fully understood.

Hypothesis: Inhaled sedation with isoflurane administered via the Sedaconda ACD-S system in critically ill patients leads to a shorter duration of mechanical ventilation at 28 days and a reduced length of ICU stay compared to intravenous sedation with propofol.

Main objective: To compare the number of ventilator-free days at day 28 post-randomization between critically ill patients receiving sedation with isoflurane versus those receiving intravenous sedation with propofol in critically ill patients expected to require more than 48 hours of invasive mechanical ventilation. Key secondary objective: To compare the number of ICU-free days at day 28 post-randomization in both treatment arms. Secondary objectives: To compare time to extubation after sedation withdrawal, efficacy in maintaining a target level of sedation, compare the percentage of patients requiring one or more additional hypnotics, compare the incidence and duration of delirium at day 28, assess mental, cognitive, and quality of life status at 90 days post-hospital discharge between both treatment groups.

Methodology: Phase IV, low-intervention, open-label, multicenter, randomized controlled trial with intention-to-treat analysis including mechanically ventilated patients expected to require a minimum of 48 hours of mechanical ventilation with a RASS score between -3 and -5. Patients will be randomized 1:1 to receive inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous sedation with propofol. A total of 620 patients will be included from a pool of 22 participating centers.

Conditions

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Sedation Airway Extubation

Keywords

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Inhaled sedation Mechanical ventilation Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Inhaled sedation with Isoflurane. Initial dose: 3 mL/h. Gradual dose increase until target RASS is achieved. Do not exceed 14 mL/h. Guided by end tidal isoflurane concentration (EtISO), the recommended maximum dose for prolonged use is 1%. Short periods at up to 1.5% may be considered. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.

Group Type EXPERIMENTAL

Isoflurane

Intervention Type DRUG

Inhaled sedation with isoflurane via Sedaconda ACD-S

Control group

Intravenous sedation with propofol (20 mg/mL). Initial dose: 0.5-1 mg/kg/h. Gradual dose increase until target RASS is achieved. Do not exceed 4 mg/kg/h. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Intravenous sedation with Propofol 20 mg/ml

Interventions

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Isoflurane

Inhaled sedation with isoflurane via Sedaconda ACD-S

Intervention Type DRUG

Propofol

Intravenous sedation with Propofol 20 mg/ml

Intervention Type DRUG

Other Intervention Names

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Inhaled sedation with Isoflurane Intravenous sedation with Propofol

Eligibility Criteria

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Inclusion Criteria

\- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5).

Exclusion Criteria

* Contraindication to isoflurane or propofol
* Allergy to isoflurane or propofol
* Cardiopulmonary arrest
* History of ventricular tachycardia or long QT syndrome
* Tidal volume \< 300 mL or PaCO₂ \> 50 mmHg at the time of randomization.
* Invasive mechanical ventilation for more than 48 hours at the time of randomization.
* Pregnancy
* Breast feeding
* Acute neurological condition
* ECMO
* ECCO2R
* Active humidification strictly required
* Burns
* Lack of informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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José Manuel Añón

Head of Department of Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José M. Añón, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz. IdiPAZ

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José M. Añón, MD, PhD

Role: CONTACT

Phone: +(34) 912071307

HULP6844

Identifier Type: -

Identifier Source: org_study_id

Inhaled Sedation in Critically Ill Patients

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Study group

Isoflurane

Control group

Propofol

Interventions

Isoflurane

Propofol

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Instituto de Salud Carlos III

Instituto de Investigación Hospital Universitario La Paz

Responsible Party

José Manuel Añón

Principal Investigators

José M. Añón, MD, PhD

Locations

Hospital Vega Baja

Hospital Universitario Doctor José Molina Orosa

Hospital Universitario de Albacete

Hospital Germans Trias i Pujol

Corporacio Sanitaria Parc Taulí

Hospital Universitario de Bellvitge

Hospital Universitario Valle de Hebron

Hospital General Universitario Santa Lucía

Hospital Arnau de Vilanova

Hospital Universitario La Paz

Hospital Univeritario Puerta de Hierro

Hospital Universitario de Getafe

Hospital Universitario de la Princesa

Hospital Universitario Gregorio Marañon

Hospital Universitario Infanta Leonor

Hospital Universitario Rey Juan Carlos

Hospital Reina Sofía

Hospital Universitario Virgen de la Arrixaca

Hospital Universitario Joan XXIII

Hospital Universitario de Toledo

Hospital Clínico Universitario de Valencia

Hospital Universitario Rio Hortega

Countries

Central Contacts

José M. Añón, MD, PhD

Facility Contacts

Carola Gimenez-Esparza, MD

Andoni García-Muñoz, MD

Jose M. Gutierrez

Paula Pedreira

Manel Santafe, MD

Paola Cardenas

Raquel S. Contreras, MD

Agueda Ojados

Jesús Caballero, MD, PhD

José M Añón, MD, PhD

Sara Alcántara, MD,PhD

Carmen Rodriguez Solís

Aris Perez Lucendo, MD

José M. Gomez, MD

María Paz Escuela, MD, PhD

Manuel Pérez Torres

Julian Triviño

Ana del Saz, MD

Oriol Plans

Mario Dalorzo

Monica García Simon, MD

Ana Prieto

Other Identifiers

2024-518521-14-00

HULP6844