Cost-Effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Adults

NCT07734350 | Not Yet Recruiting FDA Drug

• 1 other identifier: CEI2026-16/04/V1
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn whether inhaled sedation is a cost-effective alternative to intravenous propofol in mechanically ventilated critically ill adults admitted to the intensive care unit. The main questions it aims to answer are:

• Does inhaled sedation reduce the total cost of care compared with intravenous propofol?
• Does inhaled sedation reduce the duration of mechanical ventilation and ICU length of stay?
• Are adverse events different between patients receiving inhaled sedation and those receiving intravenous propofol? Researchers will compare patients who received inhaled sedation with patients who received intravenous propofol to see if inhaled sedation improves clinical outcomes and reduces overall costs. Participants will:
• Be identified through review of electronic medical records
• Be included if they are adults who received mechanical ventilation and were sedated with inhaled sedation or intravenous propofol
• Contribute data on total costs of care, duration of mechanical ventilation, ICU length of stay, and adverse event

Conditions

Critical Illness; Mechanical Ventilation; Respiratory Insufficiency

Keywords

Inhaled sedation; Propofol; Mechanical ventilation; Critical illness; Intensive care unit; Cost-effectiveness; Critical care sedation; Adult ICU patients

Outcome Measures

Primary Outcomes (1)

• Total Cost of Care

  Through ICU discharge, an average of 7 days

Study Arms (2)

Inhaled Sedation Cohort

This cohort includes adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received inhaled sedation as their primary sedation strategy during ICU stay. In the study protocol, inhaled sedation is defined as the use of isoflurane administered through an anesthetic-conserving device. Patients in this cohort will be identified retrospectively through electronic medical record review and will be evaluated for total cost of care, duration of mechanical ventilation, ICU length of stay, adverse events, and relevant clinical covariates including age, sex, SOFA score, APACHE II score, and comorbidities. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.

Drug: Isoflurane

Intravenous Propofol Cohort

This cohort includes adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received continuous intravenous propofol as their primary sedation strategy during ICU stay. These patients will also be identified retrospectively through review of electronic medical records and will serve as the comparison group for the cost-effectiveness analysis. Outcomes assessed in this cohort will include total cost of care, duration of mechanical ventilation, ICU length of stay, adverse events, and indirect costs, as well as baseline and clinical covariates such as age, sex, SOFA score, APACHE II score, and comorbidities. The same exclusion criteria will be applied to maintain comparability between cohorts.

Drug: Propofol (Astra-Zeneca)

Interventions

Isoflurane DRUG

Isoflurane administered as inhaled sedation through an anesthetic-conserving device in mechanically ventilated critically ill adult patients in the intensive care unit.

Inhaled Sedation Cohort

Propofol (Astra-Zeneca) DRUG

Propofol administered as continuous intravenous sedation in mechanically ventilated critically ill adult patients in the intensive care unit.

Intravenous Propofol Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received either inhaled sedation with isoflurane or continuous intravenous propofol sedation during ICU stay will be selected through retrospective review of electronic medical records

You may qualify if:

• Adults aged 18 years or older
• Admission to the intensive care unit at Hospital H+ Querétaro
• Invasive mechanical ventilation for at least 24 hours
• Receipt of inhaled sedation or continuous intravenous propofol sedation during ICU stay

You may not qualify if:

• Extracorporeal membrane oxygenation
• Severe traumatic brain injury
• Transfer to another hospital unit
• Less than 24 hours of mechanical ventilation

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

Related Publications (8)

• Ramos FJDS, Santos MHCD, Pastore L Junior. Sedation with volatile anesthetics in the intensive care unit: a new option with old agents. Crit Care Sci. 2023 Mar 1;35(1):100-101. doi: 10.5935/2965-2774.20230394-en. No abstract available.

  PMID: 37712735 BACKGROUND

• Fudickar A, Bein B. Propofol infusion syndrome: update of clinical manifestation and pathophysiology. Minerva Anestesiol. 2009 May;75(5):339-44.

  PMID: 19412155 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.

  PMID: 21445642 BACKGROUND

• Jerath A, Parotto M, Wasowicz M, Ferguson ND. Volatile Anesthetics. Is a New Player Emerging in Critical Care Sedation? Am J Respir Crit Care Med. 2016 Jun 1;193(11):1202-12. doi: 10.1164/rccm.201512-2435CP.

  PMID: 27002466 BACKGROUND

• Al Aseri Z, Alansari MA, Al-Shami SA, Alaskar B, Aljumaiah D, Elhazmi A. The advantages of inhalational sedation using an anesthetic-conserving device versus intravenous sedatives in an intensive care unit setting: A systematic review. Ann Thorac Med. 2023 Oct-Dec;18(4):182-189. doi: 10.4103/atm.atm_89_23. Epub 2023 Oct 17.

  PMID: 38058786 BACKGROUND

• Jabaudon M, Zhai R, Blondonnet R, Bonda WLM. Inhaled sedation in the intensive care unit. Anaesth Crit Care Pain Med. 2022 Oct;41(5):101133. doi: 10.1016/j.accpm.2022.101133. Epub 2022 Jul 27.

  PMID: 35907598 BACKGROUND

• Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.

  PMID: 27611637 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.

  PMID: 30113379 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Interventions

Isoflurane; Propofol

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 29, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07