Clinical trial NCT06809218: A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
Official title: INSPiRE-ICU 1 & 2: A Pooled Analysis of Long-Term Outcomes at 3 and 6 Months After Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Post-Intensive Care Syndrome
Sedation
Keywords: Sedation
Inhaled Sedation
Long-term Outcomes
Cognitive Outcomes
INSPiRE-ICU
Post-Traumatic Stress Disorder
Activities and Daily Living
Quality of Life
Lead sponsor: Sedana Medical
Sponsor class: INDUSTRY
Collaborators: name: Critical Illness, Brain Dysfunction, and Survivorship Center
First posted: 2025-02-05
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pooled analysis will assess Cognitive, Mental Health, Functioning, and Quality of Life Assessments data from the Phase 3 registration studies INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296) to explore potential differences in Long-Term Outcomes at 3 and 6 months after treatment between critically ill mechanically ventilated patients sedated with inhaled isoflurane compared to sedated with intravenous propofol.

The analyses were pre-planned and agreed prior to completion of enrollment of either study.

Detailed description: SED003 and SED004 are two Phase 3 studies conducted in the US, with a goal to demonstrate non-inferiority of isoflurane administered via Sedaconda ACD-S to the current standard of care (SOC), IV propofol infusion, in patients requiring sedation and mechanical ventilation in the ICU.

These studies are therapeutic confirmatory (Phase 3), multicenter, randomized, controlled, open-label, assessor-blinded studies. Approximately 470 patients receiving mechanical ventilation and requiring continuous sedation at approximately 30 sites in total in the United States (US) will be randomized in a 1.5:1 ratio to inhaled isoflurane (administered via the Sedaconda ACD-S device) or propofol (administered via IV infusion) for sedation, respectively. In addition, approximately 3 to 5 run-in training patients per site will be enrolled. The treatment duration is expected to be at least 12 hours and may last up to 48 (±6) hours or to the time for extubation, whichever occurs first, with a follow up period of 6 months.

Patients eligible for the studies will either have planned surgery with anticipated need for sedation and mechanical ventilation in the ICU (ie, postoperative patients) for \>12 hours or have already been admitted to the ICU and anticipate needing sedation and mechanical ventilation for \>12 hours.

For further information about the studies, refer to INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296).

In drug studies of critically ill patients, outcomes may be assessed at remote timepoints and not merely in the ICU. This is because the "success" of interventions is not defined merely by their impact in the hospital but also by their persistent effects. The CIBS Center at Vanderbilt University Medical Center will conduct the long-term outcome assessments for a subset of patients in the INSPiRE-ICU studies.

A comprehensive battery that combines tests from diverse and relevant domains of functioning and balances the need to be sufficiently challenging to patients as well as the need to be feasibly administered and well tolerated. Crucially, this battery can be given by telephone, which allows for it to be administered by the CIBS Center to individuals from around the country, regardless of which enrollment sites they are from.

A significant proportion of the enrolled patients in the two studies will not have any follow-up data due to expected mortality as well as loss to follow-up. Since the two studies (INSPiRE-ICU 1 \& 2) are identical in design and long-term follow-up is standardized and centralized, pooling of the long-term outcomes allows for improved precision of analyses.

Eligibility criteria: Inclusion Criteria:

1. Patients who are enrolled in INSPiRE-ICU1 (NCT05312385) or INSPiRE-ICU2 (NCT05327296) and survived to discharge.

Primary outcomes:
measure: To compare cognitive function 3 months post randomization in isoflurane- vs propofol-treated patients
timeFrame: 3 months post Randomization
Secondary outcomes:
measure: To compare memory panorama from time in the ICU in isoflurane- vs propofol-treated patients
timeFrame: 3 months post Randomization
measure: To compare physical outcomes and trajectories at 3 and 6 months post randomization in isoflurane- vs propofol-treated patients
timeFrame: 3 and 6 months post Randomization
measure: To compare depressive symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients
timeFrame: 3 months post Randomization
measure: To compare anxiety symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients
timeFrame: 3 months post Randomization
measure: To compare post-traumatic stress symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients
timeFrame: 3 months post Randomization
measure: To compare quality of life at 3 months post randomization in isoflurane- vs propofol-treated patients
timeFrame: 3 months post Randomization
Other outcomes:
Locations:
city: Nashville
country: United States
facility: The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center
state: Tennessee
Study officials:
affiliation: Chief Medical Officer
name: Peter Sackey, MD, PhD
role: STUDY_CHAIR
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