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

January 29, 2025 updated by: Sedana Medical

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled isoflurane administered via Sedaconda ACD-S
Intervention: isoflurane
Drug: Inhaled isoflurane administered by Sedaconda ACD-S
Intervention: isoflurane
Active Comparator: Propofol administered as intravenous infusion
Treatment: propofol
Drug: Intravenous infusion of propofol
Intervention: propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare cognitive function 3 months post randomization in isoflurane- vs propofol-treated patients
Time Frame: 3 months post Randomization

A patient is classified as cognitive impaired if the patient has a score 2 SD (or more) worse than population mean for one test or has a score 1.5 SD (or more) worse than population mean in two or more of the following tests: TICS, WAIS IV Digit Span, Hayling Sentence Completion Test, Controlled Oral Word Association, WMS IV - Immediate Memory (Adult/Older Adult) and WMS IV - Delayed Memory (Adult/Older Adult), at 3 months post randomization.

The analysis will take into account age, sex, level of education, total IQCODE score at baseline, total SAPS total score at baseline, medical or surgical admission duration of mechanical ventilation before randomization, study drug and treatment duration as factors.
3 months post Randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare memory panorama from time in the ICU in isoflurane- vs propofol-treated patients
Time Frame: 3 months post Randomization
Number of factual memories, memories of feelings, or delusional memories, as assessed by the ICU Memory Tool, collected at 3 months follow-up
3 months post Randomization
To compare physical outcomes and trajectories at 3 and 6 months post randomization in isoflurane- vs propofol-treated patients
Time Frame: 3 and 6 months post Randomization
Activities of daily living, as assessed by the Katz ADL, at 3 and 6 months post randomization. Score ranges between 0 and 6, where 0 is the worst outcome.
3 and 6 months post Randomization
To compare depressive symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients
Time Frame: 3 months post Randomization
Depression, as assessed by PROMIS Depression questionnaire, at 3 months post randomization
3 months post Randomization
To compare anxiety symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients
Time Frame: 3 months post Randomization
Anxiety symptoms, as assessed by PROMIS Anxiety questionnaire, at 3 months post randomization
3 months post Randomization
To compare post-traumatic stress symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients
Time Frame: 3 months post Randomization
Post-traumatic stress symptoms, as assessed by IES-R, at 3 months post randomization
3 months post Randomization
To compare quality of life at 3 months post randomization in isoflurane- vs propofol-treated patients
Time Frame: 3 months post Randomization
Quality of life at 3 months post-randomization, as assessed by WHODAS 2.0
3 months post Randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sedana Medical

Collaborators

Critical Illness, Brain Dysfunction, and Survivorship Center

Investigators

  • Study Chair: Peter Sackey, MD, PhD, Chief Medical Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Actual)

November 14, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SED003_SED004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedation

Clinical Trials on Inhaled isoflurane administered by Sedaconda ACD-S

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe