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ACTIVE NOT RECRUITING
NCT06809218
PHASE3

A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol

Sponsor: Sedana Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

312

Start Date

2022-04-22

Completion Date

2025-01-30

Last Updated

2025-02-05

Healthy Volunteers

No

Interventions

DRUG

Inhaled isoflurane administered by Sedaconda ACD-S

Intervention: isoflurane

DRUG

Intravenous infusion of propofol

Intervention: propofol

Locations (1)

The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center

Nashville, Tennessee, United States