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Inhalational Sedation and Mechanical Power

Primary Purpose

Mechanical Ventilation, Sedation, Mechanical Power

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Inhalational sedation
Convention sedation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional sedation

Inhalational sedation

Arm Description

Conventional sedation receiving analgosedation with fentanyl

Inhalational sedation receiving isoflurane for sedation for 12 hours

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in oxygenation
Change in oxygenation from Phase 1 to Phase 2 compared between 2 groups
Change in respiratory mechanic
Change in respiratory mechanic from Phase 1 to Phase 2 compared between 2 groups
Change in serum interleukin 6
Change in serum interleukin 6 from Phase 1 to Phase 2 compared between 2 groups
Change in serum C-reactive protein
Change in serum C-reactive protein from Phase 1 to Phase 2 compared between 2 groups

Full Information

First Posted
September 26, 2022
Last Updated
March 13, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05559970
Brief Title
Inhalational Sedation and Mechanical Power
Official Title
Effect of Inhalational Sedation on Mechanical Power in Mechanically Ventilated Patients: a Pilot Open-label Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Sedation, Mechanical Power, Lung Injury, ICU

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional sedation
Arm Type
Active Comparator
Arm Description
Conventional sedation receiving analgosedation with fentanyl
Arm Title
Inhalational sedation
Arm Type
Experimental
Arm Description
Inhalational sedation receiving isoflurane for sedation for 12 hours
Intervention Type
Drug
Intervention Name(s)
Inhalational sedation
Intervention Description
Inhalational sedation with isoflurane for 12 hours
Intervention Type
Drug
Intervention Name(s)
Convention sedation
Intervention Description
Conventional sedation receiving analgosedation with fentanyl
Primary Outcome Measure Information:
Title
Change in mechanical power
Description
Change in mechanical power from Phase 1 to Phase 2 compared between 2 groups
Time Frame
At 15 hours after intervention applied
Secondary Outcome Measure Information:
Title
Change in oxygenation
Description
Change in oxygenation from Phase 1 to Phase 2 compared between 2 groups
Time Frame
At 15 hours after intervention applied
Title
Change in respiratory mechanic
Description
Change in respiratory mechanic from Phase 1 to Phase 2 compared between 2 groups
Time Frame
At 15 hours after intervention applied
Title
Change in serum interleukin 6
Description
Change in serum interleukin 6 from Phase 1 to Phase 2 compared between 2 groups
Time Frame
At 15 hours after intervention applied
Title
Change in serum C-reactive protein
Description
Change in serum C-reactive protein from Phase 1 to Phase 2 compared between 2 groups
Time Frame
At 15 hours after intervention applied

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annop Piriyapatsom, MD
Phone
+6624197990
Email
annop.pir@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annop Piriyapatsom, MD
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annop Piriyapatsom, M.D.
Phone
+66922819241
Email
annop.pir@mahidol.ac.th

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan of sharing individual participant data at this time.
Citations:
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Inhalational Sedation and Mechanical Power

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