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Analgosedation is usually given to critically ill patients admitted in ICU. Fentanyl is the most common agent used for this purpose. For sedative agent, midazolam and propofol are commonly administered. However, too much sedation is apparently associated with increased duration of mechanical ventilation, prolonged ICU stay, and increased mortality.
In mechanically ventilated patients, mechanical power is the respiratory mechanic that can predict clinical outcomes including mortality in both ARDS and non-ARDS patients. Previous study demonstrated that sedating mechanically ventilated patients with propofol could decreased mechanical power. This was possibly associated with improved clinical outcomes in these patients.
At present, there is no clinical study investigating effects of inhalation sedation on mechanical power and clinical outcomes in mechanically ventilated patients.
In the intensive care unit (ICU), sedation is used to improve comfort and tolerance during mechanical ventilation, invasive diagnostic and therapeutic interventions or nursing care. The most commonly used sedatives are intravenous benzodiazepines and propofol. These agents are associated with over-sedation in 40 to 60% of patients, which can lead to prolonged intubation, delirium and drug-induced hypotension. Volatile anesthetics are increasingly used for sedation in European and Canadian intensive care units that offer advantages of rapid drug on and off effects and clearance via pulmonary exhalation with no active metabolites. Delivery of volatile agents in the ICU can be simply performed using a small lightweight and portable anesthetic reflector so-called anesthesia conserving device. Compared with intravenous sedatives, volatile anesthetics may allow shorter time to extubation and can facilitate mental recovery.
In mechanically ventilated patients, a growing body of evidence suggests that the mechanical power (MP) plays an important role in the ventilator-induce lung injury (VILI) and prognosis in in both acute respiratory distress syndrome (ARDS) and non-ARDS patients. MP is the energy per unit time released to the respiratory system according to the tidal volume, PEEP, respiratory rate, and flow applied. In ARDS patients receiving invasive mechanical ventilation, high MP was associated an increased mortality. Moderate to deep sedation can inhibit the respiratory center and reduces the excessive respiratory drive, thereby reducing transpulmonary pressure and MP as well as probably reducing lung injury. The purpose of this study aims to investigate the effect of inhalation sedation on MP in mechanically ventilated patient admitted in the ICU. We hypothesize that MP in mechanically ventilated patients can be reduced by administering inhalational sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional sedation | Active Comparator | Conventional sedation receiving analgosedation with fentanyl |
|
| Inhalational sedation | Experimental | Inhalational sedation receiving isoflurane for sedation for 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalational sedation | Drug | Inhalational sedation with isoflurane for 12 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mechanical power | Change in mechanical power from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygenation | Change in oxygenation from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied |
| Change in respiratory mechanic | Change in respiratory mechanic from Phase 1 to Phase 2 compared between 2 groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annop Piriyapatsom, MD | Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22549581 | Background | Grap MJ, Munro CL, Wetzel PA, Best AM, Ketchum JM, Hamilton VA, Arief NY, Pickler R, Sessler CN. Sedation in adults receiving mechanical ventilation: physiological and comfort outcomes. Am J Crit Care. 2012 May;21(3):e53-63; quiz e64. doi: 10.4037/ajcc2012301. | |
| 27002466 | 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. |
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There is no plan of sharing individual participant data at this time.
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| ID | Term |
|---|---|
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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| Convention sedation |
| Drug |
Conventional sedation receiving analgosedation with fentanyl |
|
| At 15 hours after intervention applied |
| Change in serum interleukin 6 | Change in serum interleukin 6 from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied |
| Change in serum C-reactive protein | Change in serum C-reactive protein from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied |
| 30923729 | Background | Koutsogiannaki S, Shimaoka M, Yuki K. The Use of Volatile Anesthetics as Sedatives for Acute Respiratory Distress Syndrome. Transl Perioper Pain Med. 2019;6(2):27-38. doi: 10.31480/2330-4871/084. Epub 2019 Feb 21. |
| 29700664 | Background | Bomberg H, Meiser F, Zimmer S, Bellgardt M, Volk T, Sessler DI, Groesdonk HV, Meiser A. Halving the volume of AnaConDa: initial clinical experience with a new small-volume anaesthetic reflector in critically ill patients-a quality improvement project. J Clin Monit Comput. 2018 Aug;32(4):639-646. doi: 10.1007/s10877-018-0146-z. Epub 2018 Apr 26. |
| 27828800 | Background | Jerath A, Panckhurst J, Parotto M, Lightfoot N, Wasowicz M, Ferguson ND, Steel A, Beattie WS. Safety and Efficacy of Volatile Anesthetic Agents Compared With Standard Intravenous Midazolam/Propofol Sedation in Ventilated Critical Care Patients: A Meta-analysis and Systematic Review of Prospective Trials. Anesth Analg. 2017 Apr;124(4):1190-1199. doi: 10.1213/ANE.0000000000001634. |
| 27238433 | Background | Landoni G, Pasin L, Cabrini L, Scandroglio AM, Baiardo Redaelli M, Votta CD, Bellandi M, Borghi G, Zangrillo A. Volatile Agents in Medical and Surgical Intensive Care Units: A Meta-Analysis of Randomized Clinical Trials. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):1005-14. doi: 10.1053/j.jvca.2016.02.021. Epub 2016 Feb 23. |
| 32448389 | Background | Coppola S, Caccioppola A, Froio S, Formenti P, De Giorgis V, Galanti V, Consonni D, Chiumello D. Effect of mechanical power on intensive care mortality in ARDS patients. Crit Care. 2020 May 24;24(1):246. doi: 10.1186/s13054-020-02963-x. |
| 33784486 | Background | Costa ELV, Slutsky AS, Brochard LJ, Brower R, Serpa-Neto A, Cavalcanti AB, Mercat A, Meade M, Morais CCA, Goligher E, Carvalho CRR, Amato MBP. Ventilatory Variables and Mechanical Power in Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2021 Aug 1;204(3):303-311. doi: 10.1164/rccm.202009-3467OC. |
| 30291378 | Background | Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5. |
| 32653011 | Background | Chiumello D, Gotti M, Guanziroli M, Formenti P, Umbrello M, Pasticci I, Mistraletti G, Busana M. Bedside calculation of mechanical power during volume- and pressure-controlled mechanical ventilation. Crit Care. 2020 Jul 11;24(1):417. doi: 10.1186/s13054-020-03116-w. |
| 32016537 | Background | Spinelli E, Mauri T, Beitler JR, Pesenti A, Brodie D. Respiratory drive in the acute respiratory distress syndrome: pathophysiology, monitoring, and therapeutic interventions. Intensive Care Med. 2020 Apr;46(4):606-618. doi: 10.1007/s00134-020-05942-6. Epub 2020 Feb 3. |
| 32204710 | Background | Jonkman AH, de Vries HJ, Heunks LMA. Physiology of the Respiratory Drive in ICU Patients: Implications for Diagnosis and Treatment. Crit Care. 2020 Mar 24;24(1):104. doi: 10.1186/s13054-020-2776-z. |
| 28146639 | Background | Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI. |
| 32351988 | Background | Xie Y, Cao L, Qian Y, Zheng H, Liu K, Li X. Effect of Deep Sedation on Mechanical Power in Moderate to Severe Acute Respiratory Distress Syndrome: A Prospective Self-Control Study. Biomed Res Int. 2020 Apr 11;2020:2729354. doi: 10.1155/2020/2729354. eCollection 2020. |