MedTrace Logo

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

NCT06809218 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

  • Post-Intensive Care Syndrome
  • Sedation

Interventions

DRUG

Inhaled isoflurane administered by Sedaconda ACD-S

Intervention: isoflurane

DRUG

Intravenous infusion of propofol

Intervention: propofol

Sponsors & Collaborators

  • Critical Illness, Brain Dysfunction, and Survivorship Center

    collaborator UNKNOWN

  • Sedana Medical

    lead INDUSTRY

Principal Investigators

  • Peter Sackey, MD, PhD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2024-11-14
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809218 on ClinicalTrials.gov