Inhalational Sedation and Mechanical Power

NCT05559970 | Unknown

• 1 other identifier: 385/2565(IRB2)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation; Sedation; Mechanical Power; Lung Injury; ICU

Outcome Measures

Primary Outcomes (1)

• Change in mechanical power

  Change in mechanical power from Phase 1 to Phase 2 compared between 2 groups

  At 15 hours after intervention applied

Secondary Outcomes (4)

• Change in oxygenation

  At 15 hours after intervention applied

• Change in respiratory mechanic

  At 15 hours after intervention applied

• Change in serum interleukin 6

  At 15 hours after intervention applied

• Change in serum C-reactive protein

  At 15 hours after intervention applied

Study Arms (2)

Conventional sedation

ACTIVE COMPARATOR

Conventional sedation receiving analgosedation with fentanyl

Drug: Convention sedation

Inhalational sedation

EXPERIMENTAL

Inhalational sedation receiving isoflurane for sedation for 12 hours

Drug: Inhalational sedation

Interventions

Inhalational sedation DRUG

Inhalational sedation with isoflurane for 12 hours

Inhalational sedation

Convention sedation DRUG

Conventional sedation receiving analgosedation with fentanyl

Conventional sedation

Eligibility Criteria

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

You may qualify if:

• Patient with age \>18 years old; and
• Patient who is admitted to the participating ICU; and

You may not qualify if:

• Patient with history or suspected history of malignant hyperthermia
• Patient with evident or suspected increased intracranial pressure
• Patient with high severity of illness whose ICU survival is not expected
• Patient who refuses or patient whose proxy refuses to participate in the study

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (14)

• 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.

  PMID: 22549581 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

• 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.

  PMID: 30923729 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.

  PMID: 29700664 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.

  PMID: 27828800 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.

  PMID: 27238433 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.

  PMID: 32448389 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.

  PMID: 33784486 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.

  PMID: 30291378 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.

  PMID: 32653011 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.

  PMID: 32016537 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.

  PMID: 32204710 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.

  PMID: 28146639 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.

  PMID: 32351988 BACKGROUND

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Annop Piriyapatsom, MD

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annop Piriyapatsom, MD

CONTACT

+6624197990; annop.pir@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 15, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)