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This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.
This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit (ICU) adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoflurane | Experimental | Inhaled isoflurane administered via Sedaconda ACD-S |
|
| Propofol | Active Comparator | Propofol administered as intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoflurane | Drug | Inhaled isoflurane administered by Sedaconda ACD-S |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients | The Target Range is RASS -1 to -4. The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4: +4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Drowsy - Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice for more than 10 seconds. -2 Light sedation - Briefly awakens with eye contact to voice for less than 10 seconds. -3 Moderate sedation - Movement or eye opening to voice, but no eye contact. -4 Deep sedation - No response to voice, but movement or eye opening to physical stimulation. -5 Unarousable - No response to voice or physical stimulation. | From start to end of study treatment (up to 48 (±6) hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period | To compare the effect of isoflurane vs propofol on use of opioids during the study treatment period by measuring change in mean fentanyl-equivalent opioid dose during the study treatment period compared to mean opioid dose during the 60 minutes prior to baseline | From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Rengel, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30113379 | Background | 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. | |
| 31112380 |
| Label | URL |
|---|---|
| Isoflurane 100% inhalation vapour, liquid. Summary of product characteristics. West Drayton, United Kingdon. Piramal Critical Care Ltd. Electronic medicines compendium(emc), last updated 29 October 2019. Accessed 09 September 2020. | View source |
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3-5 run-in participants treated with isoflurane were enrolled at each site prior to randomization.
Run-ins are not analyzed separately, only included in the safety population together with the randomized participants that received at least one dose of study drug.
In total 42 run-ins (37 with at least one dose of study drug), 142 randomized isoflurane participants (140 with at least one dose of study drug) and 93 randomized propofol participants (89 with at least one dose of study drug)).
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| ID | Title | Description |
|---|---|---|
| FG000 | Isoflurane (Run-ins) | Inhaled isoflurane administered via Sedaconda ACD-S 3-5 run-in patients treated with isoflurane were enrolled at each site prior to randomization. The run-ins are only assessed for safety, together with the portion of patients randomized to isoflurane and receiving at least one dose of study drug |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2023 |
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| Propofol |
| Drug |
Intravenous infusion of propofol |
|
| Isoflurane (run-ins) | Drug | Inhaled isoflurane administered by Sedaconda ACD-S 3-5 run-in patients were enrolled at each site prior to randomization |
|
| Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment | Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours) |
| Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | Cognitive recovery will be assessed by the 7-point scale of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7) at 60 (±10) minutes after end of study drug treatment in patients not re-sedated with benzodiazepine or propofol infusions. The scale ranges from 0 to 7, with higher scores indicating more severe delirium. | At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours) |
| Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period | Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period | From start to end of study treatment, up to 48 (±6) hours |
| Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation | To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation | From end of study treatment sedation to extubation (up to 7 Days after randomization) |
| Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30 | From start of study treatment up to 30 days |
| Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU | From start of study treatment up to 30 days |
| Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment | From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation) |
| Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization | Participants reported represent participants that died between randomization and 30 days in the Safety population | At 30 days after randomization |
| Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization | Participants reported represent participants that died between randomization and 3 months in the Safety population | At 3 months after randomization |
| Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization | Participants reported represent participants that died between randomization and 6 months in the Safety population | At 6 months after randomization |
| Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane | From start to end of study treatment (up to 48 (±6) hours) |
| Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol | Incidence of restraints measured twice daily | From start to end of study treatment (up to 48 (±6) hours) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| The Brigham and Women´s Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Intermountain Health Care Health Services | Salt Lake City | Utah | 84111 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Background |
| 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. |
| 10816184 | Background | 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. |
| 23180503 | Background | 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. |
| 18431266 | Background | 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. |
| 21445642 | Background | 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. |
| 34454654 | Background | 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. |
| 2500195 | Background | 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. |
| 33170331 | Background | 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. |
| 32588067 | Background | 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. |
| 25793760 | Background | 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. |
| 33528922 | Background | 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. |
| 27941501 | Background | 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. |
| 18191684 | Background | 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. |
| 24088092 | Background | 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. |
| 39461861 | Derived | Boncyk C, Devlin JW, Faisal H, Girard TD, Hsu SH, Jabaley CS, Sverud I, Falkenhav M, Kress J, Sheppard K, Sackey PV, Hughes CG. INhaled Sedation versus Propofol in REspiratory failure in the Intensive Care Unit (INSPiRE-ICU1): protocol for a randomised, controlled trial. BMJ Open. 2024 Oct 26;14(10):e086946. doi: 10.1136/bmjopen-2024-086946. |
| Isoflurane |
Inhaled isoflurane administered via Sedaconda ACD-S Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S |
| FG002 | Propofol | Propofol administered as intravenous infusion Propofol: Intravenous infusion of propofol |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Isoflurane (Run-ins) | Inhaled isoflurane administered via Sedaconda ACD-S. Approximately 3-5 run-in patients were treated at each site for training purposes. |
| BG001 | Isoflurane (Randomized) | Inhaled isoflurane administered via Sedaconda ACD-S All randomized patients |
| BG002 | Propofol (Randomized) | Propofol administered as intravenous infusion All randomized patients |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients | The Target Range is RASS -1 to -4. The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4: +4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Drowsy - Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice for more than 10 seconds. -2 Light sedation - Briefly awakens with eye contact to voice for less than 10 seconds. -3 Moderate sedation - Movement or eye opening to voice, but no eye contact. -4 Deep sedation - No response to voice, but movement or eye opening to physical stimulation. -5 Unarousable - No response to voice or physical stimulation. | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Mean | Standard Deviation | % of time of adequate sedation depth | From start to end of study treatment (up to 48 (±6) hours) |
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| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period | To compare the effect of isoflurane vs propofol on use of opioids during the study treatment period by measuring change in mean fentanyl-equivalent opioid dose during the study treatment period compared to mean opioid dose during the 60 minutes prior to baseline | This Outcome Measures was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Mean | Standard Deviation | µg/kg/hr fentanyl equivalents | From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours) |
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| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment | This Outcome Measures was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Median | Inter-Quartile Range | minutes | Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours) |
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| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | Cognitive recovery will be assessed by the 7-point scale of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7) at 60 (±10) minutes after end of study drug treatment in patients not re-sedated with benzodiazepine or propofol infusions. The scale ranges from 0 to 7, with higher scores indicating more severe delirium. | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Count of Participants | Participants | At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours) |
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| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period | Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Mean | Standard Deviation | % of spontaneous breathing efforts | From start to end of study treatment, up to 48 (±6) hours |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation | To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Median | Inter-Quartile Range | minutes | From end of study treatment sedation to extubation (up to 7 Days after randomization) |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30 | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Least Squares Mean | 95% Confidence Interval | Days | From start of study treatment up to 30 days |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Posted | Least Squares Mean | 95% Confidence Interval | Days | From start of study treatment up to 30 days |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment | This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug) | Posted | Mean | Standard Deviation | Days | From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation) |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization | Participants reported represent participants that died between randomization and 30 days in the Safety population | Posted | Count of Participants | Participants | At 30 days after randomization |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization | Participants reported represent participants that died between randomization and 3 months in the Safety population | Posted | Count of Participants | Participants | At 3 months after randomization |
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| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization | Participants reported represent participants that died between randomization and 6 months in the Safety population | Posted | Count of Participants | Participants | At 6 months after randomization |
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| Secondary | Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane | This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug) | Posted | Number | Device Deficiencies | From start to end of study treatment (up to 48 (±6) hours) |
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| Secondary | Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol | Incidence of restraints measured twice daily | This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug) | Posted | Count of Participants | Participants | From start to end of study treatment (up to 48 (±6) hours) |
|
|
Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs.
AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isoflurane (Run-ins and Randomized) | Inhaled isoflurane administered via Sedaconda ACD-S 3-5 run-in patients treated with isoflurane were enrolled at each site prior to randomization. | 58 | 177 | 31 | 177 | 55 | 177 |
| EG001 | Propofol (Randomized) | Propofol administered as intravenous infusion | 31 | 89 | 14 | 89 | 22 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Unintentional medical device removal | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Therapy cessation | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
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| Hospice care | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Development and Operations | Sedana Medical | +46 (0)8 124 05 200 | medinfo@sedanamedical.com |
| May 18, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007530 | Isoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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