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Mechanical VentilationNCT05559970

Inhalational Sedation and Mechanical Power

A study testing Inhalational sedation and Convention sedation in people with Mechanical Ventilation and Sedation, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mechanical Ventilation, Sedation, Mechanical Power
What is being tested?
Inhalational sedation and Convention sedation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteThailand
Study dates
15 Nov 2022to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Patient with age >18 years old; and
  • Patient who is admitted to the participating ICU; and
  • Patient who receives respiratory support with invasive mechanical ventilation via endotracheal tube < 12 hours prior to inclusion with anticipated duration of > 48 hours

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: Effect of Inhalational Sedation on Mechanical Power in Mechanically Ventilated Patients: a Pilot Open-label Randomized Controlled Study

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.

Read the detailed description

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.

Being tested
Inhalational sedation, Convention sedation
Medical subject headings
Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhalational sedationDrug

    Inhalational sedation with isoflurane for 12 hours

  • Convention sedationDrug

    Conventional sedation receiving analgosedation with fentanyl

Study groups in NCT05559970
Study groupRoleWhat they receive
Conventional sedationActive comparatorConventional sedation receiving analgosedation with fentanyl
Receives: Drug: Convention sedation
Inhalational sedationExperimentalInhalational sedation receiving isoflurane for sedation for 12 hours
Receives: Drug: Inhalational sedation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mechanical power

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

    Measured: At 15 hours after intervention applied

Secondary outcomes (4)
  1. Change in oxygenation

    Change in oxygenation from Phase 1 to Phase 2 compared between 2 groups

    Measured: At 15 hours after intervention applied

  2. Change in respiratory mechanic

    Change in respiratory mechanic from Phase 1 to Phase 2 compared between 2 groups

    Measured: At 15 hours after intervention applied

  3. Change in serum interleukin 6

    Change in serum interleukin 6 from Phase 1 to Phase 2 compared between 2 groups

    Measured: At 15 hours after intervention applied

  4. Change in serum C-reactive protein

    Change in serum C-reactive protein from Phase 1 to Phase 2 compared between 2 groups

    Measured: At 15 hours after intervention applied

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start15 Nov 2022
  3. Primary completion27 Sep 2023
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559970
Sponsor's protocol ID
385/2565(IRB2)
Status last verified
May 2026
First submitted
26 Sep 2022
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan of sharing individual participant data at this time.

Publications

  • 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.

    PubMed 22549581
  • 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.

    PubMed 27002466
  • 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.

    PubMed 30923729
  • 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.

    PubMed 29700664
  • 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.

    PubMed 27828800
  • 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.

    PubMed 27238433
  • 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.

    PubMed 32448389
  • 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.

    PubMed 33784486
  • 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.

    PubMed 30291378
  • 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.

    PubMed 32653011
  • 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.

    PubMed 32016537
  • 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.

    PubMed 32204710
  • 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.

    PubMed 28146639
  • 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.

    PubMed 32351988

Questions about this trial

What is this clinical trial studying?

A study testing Inhalational sedation and Convention sedation in people with Mechanical Ventilation and Sedation, run by Mahidol University at 1 site in Thailand.

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 3 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: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in mechanical power (time frame: At 15 hours after intervention applied). 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 NCT05559970, which also lists 14 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 7 May 2026.

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