Critical IllnessNCT07734350
Cost-Effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Adults
An observational study of Critical Illness and Mechanical Ventilation, run by Hospital H+ Queretaro.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation, Respiratory Insufficiency
- What is being tested?
- Isoflurane and Propofol (Astra-Zeneca)
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2026to 31 Oct 2026
- Phase
- Observational
- 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
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
Who may be able to join
- 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
Who cannot join
- Extracorporeal membrane oxygenation
- Severe traumatic brain injury
- Transfer to another hospital unit
- Less than 24 hours of mechanical ventilation
About this study
Official title: Cost-effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Patients: a Retrospective ICU Study
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?
Read more
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
Read the detailed description
Sedation is an essential component of care for critically ill patients receiving invasive mechanical ventilation in the intensive care unit (ICU). It helps improve patient comfort, reduce metabolic demand, and facilitate ventilator synchrony. Intravenous propofol is widely used for this purpose because of its rapid onset and titratability, but it may be associated with adverse effects such as hypotension, hyperlipidemia, and propofol infusion syndrome. Inhaled sedation with volatile anesthetic agents has re-emerged as an alternative approach in ICU patients, with potential advantages including lower drug accumulation, rapid pulmonary elimination, and possibly shorter duration of mechanical ventilation and ICU stay.
This study is a retrospective observational cohort study conducted in the ICU of Hospital H+ Querétaro. It will include adult patients who required at least 24 hours of mechanical ventilation and received either inhaled sedation or continuous intravenous propofol sedation during their ICU stay. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.
The primary objective is to compare the total cost of inhaled sedation versus intravenous propofol in mechanically ventilated critically ill patients. Secondary objectives are to compare duration of mechanical ventilation, ICU length of stay, adverse events, and indirect costs between the two sedation strategies. The primary outcome is total cost of care, while secondary outcomes include days on mechanical ventilation, ICU stay, and adverse events. Additional variables such as age, sex, SOFA score, APACHE II score, and comorbidities will also be collected.
Data will be collected through review of electronic medical records and recorded in a standardized format. Statistical analysis will be performed using STATA. Descriptive statistics will summarize baseline characteristics and outcomes, and inferential analyses will be used to compare groups, with adjustment for relevant covariates when appropriate. The aim of the study is to determine whether inhaled sedation may represent a cost-effective strategy that improves resource use and clinical outcomes in the ICU setting.
- Being tested
- Isoflurane, Propofol (Astra-Zeneca)
- Keywords
- Inhaled sedation, Propofol, Mechanical ventilation, Critical illness, Intensive care unit, Cost-effectiveness, Critical care sedation, Adult ICU patients
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Isoflurane administered as inhaled sedation through an anesthetic-conserving device in mechanically ventilated critically ill adult patients in the intensive care unit.
Propofol (Astra-Zeneca)Drug
Propofol administered as continuous intravenous sedation in mechanically ventilated critically ill adult patients in the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Propofol (Astra-Zeneca) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cost of Care
Measured: Through ICU discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start29 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734350
- Sponsor's protocol ID
- CEI2026-16/04/V1
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37712735Fudickar A, Bein B. Propofol infusion syndrome: update of clinical manifestation and pathophysiology. Minerva Anestesiol. 2009 May;75(5):339-44.
PubMed 19412155Mesnil 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 21445642Jerath 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.
PubMed 27002466Al 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.
PubMed 38058786Jabaudon 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.
PubMed 35907598Jabaudon 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.
PubMed 27611637Devlin 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Patients: a Retrospective ICU Study
- ClinicalTrials.gov ID
- NCT07734350
- Acronym / sponsor ID
- CEI2026-16/04/V1
- Keywords
- Inhaled sedation, Propofol, Mechanical ventilation, Critical illness, Intensive care unit, Cost-effectiveness, Critical care sedation, Adult ICU patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 29 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Sedation is an essential component of care for critically ill patients receiving invasive mechanical ventilation in the intensive care unit (ICU). It helps improve patient comfort, reduce metabolic demand, and facilitate ventilator synchrony. Intravenous propofol is widely used for this purpose because of its rapid onset and titratability, but it may be associated with adverse effects such as hypotension, hyperlipidemia, and propofol infusion syndrome. Inhaled sedation with volatile anesthetic agents has re-emerged as an alternative approach in ICU patients, with potential advantages including lower drug accumulation, rapid pulmonary elimination, and possibly shorter duration of mechanical ventilation and ICU stay.
This study is a retrospective observational cohort study conducted in the ICU of Hospital H+ Querétaro. It will include adult patients who required at least 24 hours of mechanical ventilation and received either inhaled sedation or continuous intravenous propofol sedation during their ICU stay. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.
The primary objective is to compare the total cost of inhaled sedation versus intravenous propofol in mechanically ventilated critically ill patients. Secondary objectives are to compare duration of mechanical ventilation, ICU length of stay, adverse events, and indirect costs between the two sedation strategies. The primary outcome is total cost of care, while secondary outcomes include days on mechanical ventilation, ICU stay, and adverse events. Additional variables such as age, sex, SOFA score, APACHE II score, and comorbidities will also be collected.
Data will be collected through review of electronic medical records and recorded in a standardized format. Statistical analysis will be performed using STATA. Descriptive statistics will summarize baseline characteristics and outcomes, and inferential analyses will be used to compare groups, with adjustment for relevant covariates when appropriate. The aim of the study is to determine whether inhaled sedation may represent a cost-effective strategy that improves resource use and clinical outcomes in the ICU setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Sedation Cohort | – | Drug: IsofluraneThis 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. |
| Intravenous Propofol Cohort | – | Drug: Propofol (Astra-Zeneca)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Extracorporeal membrane oxygenation
- Severe traumatic brain injury
- Transfer to another hospital unit
- Less than 24 hours of mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsofluraneIsoflurane administered as inhaled sedation through an anesthetic-conserving device in mechanically ventilated critically ill adult patients in the intensive care unit. | Drug | Inhaled Sedation Cohort |
| Propofol (Astra-Zeneca)Propofol administered as continuous intravenous sedation in mechanically ventilated critically ill adult patients in the intensive care unit. | Drug | Intravenous Propofol Cohort |
Primary outcome
Total Cost of Care
Time frame: Through ICU discharge, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 37712735Ramos 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.
- Background: PubMed 19412155Fudickar A, Bein B. Propofol infusion syndrome: update of clinical manifestation and pathophysiology. Minerva Anestesiol. 2009 May;75(5):339-44.
- Background: PubMed 21445642Mesnil 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.
- Background: PubMed 27002466Jerath 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.
- Background: PubMed 38058786Al 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.
- Background: PubMed 35907598Jabaudon 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.
- Background: PubMed 27611637Jabaudon 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.
- Background: PubMed 30113379Devlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Mechanical Ventilation, run by Hospital H+ Queretaro.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Total Cost of Care (time frame: Through ICU discharge, an average of 7 days). 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 NCT07734350, which also lists 8 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 29 Jul 2026.