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

Официальное название

Cost-effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Patients: a Retrospective ICU Study

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Isoflurane
  Isoflurane administered as inhaled sedation through an anesthetic-conserving device in mechanically ventilated critically ill adult patients in the intensive care unit.
• Препарат Propofol (Astra-Zeneca)
  Propofol administered as continuous intravenous sedation in mechanically ventilated critically ill adult patients in the intensive care unit.

Первичные конечные точки

• Total Cost of Care [Срок оценки: Through ICU discharge, an average of 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• Fudickar A, Bein B. Propofol infusion syndrome: update of clinical manifestation and pathophysiology. Minerva Anestesiol. 2009 May;75(5):339-44. PMID 19412155
• 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
• 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
• 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
• 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
• 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
• 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, C PMID 30113379

Идентификаторы

NCT: NCT07734350 · CEI2026-16/04/V1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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