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Post-Intensive Care SyndromePhase 3NCT06809218

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

A Phase 3 study testing Inhaled isoflurane administered by Sedaconda ACD-S and Intravenous infusion of propofol in people with Post-Intensive Care Syndrome and Sedation, run by Sedana Medical at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-Intensive Care Syndrome, Sedation
What is being tested?
Inhaled isoflurane administered by Sedaconda ACD-S and Intravenous infusion of propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteUnited States
Study dates
22 Apr 2022to 30 Jan 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Nashville, Tennessee, 37203

Other trials in United States

About this 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

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.

Read the 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.

Being tested
Inhaled isoflurane administered by Sedaconda ACD-S, Intravenous infusion of propofol
Keywords
Sedation, Inhaled Sedation, Long-term Outcomes, Cognitive Outcomes, INSPiRE-ICU, Post-Traumatic Stress Disorder, Activities and Daily Living, Quality of Life
Medical subject headings
postintensive care syndrome, Stress Disorders, Post-Traumatic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled isoflurane administered by Sedaconda ACD-SDrug

    Intervention: isoflurane

  • Intravenous infusion of propofolDrug

    Intervention: propofol

Study groups in NCT06809218
Study groupRoleWhat they receive
Inhaled isoflurane administered via Sedaconda ACD-SExperimentalIntervention: isoflurane
Receives: Drug: Inhaled isoflurane administered by Sedaconda ACD-S
Propofol administered as intravenous infusionActive comparatorTreatment: propofol
Receives: Drug: Intravenous infusion of propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare cognitive function 3 months post randomization in isoflurane- vs propofol-treated patients

    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.

    Measured: 3 months post Randomization

Secondary outcomes (6)

  1. To compare memory panorama from time in the ICU in isoflurane- vs propofol-treated patients

    Number of factual memories, memories of feelings, or delusional memories, as assessed by the ICU Memory Tool, collected at 3 months follow-up

    Measured: 3 months post Randomization

  2. To compare physical outcomes and trajectories at 3 and 6 months post randomization in isoflurane- vs propofol-treated patients

    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.

    Measured: 3 and 6 months post Randomization

  3. To compare depressive symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients

    Depression, as assessed by PROMIS Depression questionnaire, at 3 months post randomization

    Measured: 3 months post Randomization

  4. To compare anxiety symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients

    Anxiety symptoms, as assessed by PROMIS Anxiety questionnaire, at 3 months post randomization

    Measured: 3 months post Randomization

  5. To compare post-traumatic stress symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients

    Post-traumatic stress symptoms, as assessed by IES-R, at 3 months post randomization

    Measured: 3 months post Randomization

  6. To compare quality of life at 3 months post randomization in isoflurane- vs propofol-treated patients

    Quality of life at 3 months post-randomization, as assessed by WHODAS 2.0

    Measured: 3 months post Randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start22 Apr 2022
  3. Primary completion14 Nov 2024
  4. Study completion30 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809218
Sponsor's protocol ID
SED003_SED004
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

    PubMed 30113379

  • Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19.

    PubMed 31112380

  • Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

    PubMed 10816184

  • Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872.

    PubMed 23180503

  • Sackey PV, Martling CR, Carlsward C, Sundin O, Radell PJ. Short- and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam--a pilot study. Crit Care Med. 2008 Mar;36(3):801-6. doi: 10.1097/CCM.0B013E3181652FEE.

    PubMed 18431266

  • Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29.

    PubMed 21445642

  • Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.

    PubMed 34454654

  • Kong KL, Willatts SM, Prys-Roberts C. Isoflurane compared with midazolam for sedation in the intensive care unit. BMJ. 1989 May 13;298(6683):1277-80. doi: 10.1136/bmj.298.6683.1277.

    PubMed 2500195

  • Chanques G, Constantin JM, Devlin JW, Ely EW, Fraser GL, Gelinas C, Girard TD, Guerin C, Jabaudon M, Jaber S, Mehta S, Langer T, Murray MJ, Pandharipande P, Patel B, Payen JF, Puntillo K, Rochwerg B, Shehabi Y, Strom T, Olsen HT, Kress JP. Analgesia and sedation in patients with ARDS. Intensive Care Med. 2020 Dec;46(12):2342-2356. doi: 10.1007/s00134-020-06307-9. Epub 2020 Nov 10.

    PubMed 33170331

  • Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med. 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. Epub 2020 Jun 25.

    PubMed 32588067

  • Bellgardt M, Bomberg H, Herzog-Niescery J, Dasch B, Vogelsang H, Weber TP, Steinfort C, Uhl W, Wagenpfeil S, Volk T, Meiser A. Survival after long-term isoflurane sedation as opposed to intravenous sedation in critically ill surgical patients: Retrospective analysis. Eur J Anaesthesiol. 2016 Jan;33(1):6-13. doi: 10.1097/EJA.0000000000000252.

    PubMed 25793760

  • Hughes CG, Mailloux PT, Devlin JW, Swan JT, Sanders RD, Anzueto A, Jackson JC, Hoskins AS, Pun BT, Orun OM, Raman R, Stollings JL, Kiehl AL, Duprey MS, Bui LN, O'Neal HR Jr, Snyder A, Gropper MA, Guntupalli KK, Stashenko GJ, Patel MB, Brummel NE, Girard TD, Dittus RS, Bernard GR, Ely EW, Pandharipande PP; MENDS2 Study Investigators. Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis. N Engl J Med. 2021 Apr 15;384(15):1424-1436. doi: 10.1056/NEJMoa2024922. Epub 2021 Feb 2.

    PubMed 33528922

  • Krannich A, Leithner C, Engels M, Nee J, Petzinka V, Schroder T, Jorres A, Kruse J, Storm C. Isoflurane Sedation on the ICU in Cardiac Arrest Patients Treated With Targeted Temperature Management: An Observational Propensity-Matched Study. Crit Care Med. 2017 Apr;45(4):e384-e390. doi: 10.1097/CCM.0000000000002185.

    PubMed 27941501

  • Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.

    PubMed 18191684

  • Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

    PubMed 24088092

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled isoflurane administered by Sedaconda ACD-S and Intravenous infusion of propofol in people with Post-Intensive Care Syndrome and Sedation, run by Sedana Medical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare cognitive function 3 months post randomization in isoflurane- vs propofol-treated patients (time frame: 3 months post Randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06809218, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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