Inhalational Sedation and Mechanical Power

NCT ID: NCT05559970

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Conventional sedation

Conventional sedation receiving analgosedation with fentanyl

Group Type: ACTIVE_COMPARATOR

Convention sedation

Intervention Type: DRUG

Conventional sedation receiving analgosedation with fentanyl

Inhalational sedation

Inhalational sedation receiving isoflurane for sedation for 12 hours

Group Type: EXPERIMENTAL

Inhalational sedation

Intervention Type: DRUG

Inhalational sedation with isoflurane for 12 hours

Interventions

Inhalational sedation

Inhalational sedation with isoflurane for 12 hours

Intervention Type: DRUG

Convention sedation

Conventional sedation receiving analgosedation with fentanyl

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annop Piriyapatsom, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bangkok Noi, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Annop Piriyapatsom, MD

Role: CONTACT

annop.pir@mahidol.ac.th

+6624197990

Facility Contacts

Annop Piriyapatsom, M.D.

Role: primary

annop.pir@mahidol.ac.th

+66922819241

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Other Identifiers

385/2565(IRB2)

Identifier Type: -

Identifier Source: org_study_id