Inhalational Sedation and Mechanical Power

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation; Mechanical Power; ICU; Sedation; Lung Injury
• Interventions: Drug: Inhalational sedation; Drug: Convention sedation

• Registration Number: NCT05559970
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2022-11-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalational sedation	Inhalational sedation	Inhalational sedation receiving isoflurane for sedation for 12 hours
Conventional sedation	Convention sedation	Conventional sedation receiving analgosedation with fentanyl

Primary Outcome Measures

Name	Time	Method
Change in mechanical power	At 15 hours after intervention applied	Change in mechanical power from Phase 1 to Phase 2 compared between 2 groups

Secondary Outcome Measures

Name	Time	Method
Change in respiratory mechanic	At 15 hours after intervention applied	Change in respiratory mechanic from Phase 1 to Phase 2 compared between 2 groups
Change in serum interleukin 6	At 15 hours after intervention applied	Change in serum interleukin 6 from Phase 1 to Phase 2 compared between 2 groups
Change in oxygenation	At 15 hours after intervention applied	Change in oxygenation from Phase 1 to Phase 2 compared between 2 groups
Change in serum C-reactive protein	At 15 hours after intervention applied	Change in serum C-reactive protein from Phase 1 to Phase 2 compared between 2 groups

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand