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This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.
Objective: to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and RASS score compared with conventional sedation strategy (targeting RASS score alone) in patients requiring mechanical ventilation in the medical intensive care unit
The main questions it aims to answer are:
• Will titration of sedation targeting optimal respiratory drive assessed by P0.1 and arousal level improve outcomes in patients requiring mechanical ventilation in the medical ICU?
Study protocol Mechanically ventilated patients admitted to the medical ICU will be screened daily by the investigators. If the patients meet the eligibility criteria, they will be informed about the study protocol and potential risks and undergo informed consent. Then patients will be randomized in a 1:1 ratio and allocated to each study group (intervention and control group).
Researchers will compare the outcomes (rate of successful extubation, ICU and hospital mortality, ICU and hospital length of stay, duration of mechanical ventilation, amount and duration of sedation used during the study period) between the above sedation protocol (interventional group) and conventional sedation strategy (control group)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titrating sedation targeting both optimal P0.1 and appropriate arousal level | Experimental | • Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O |
|
| Titrating sedation targeting appropriate arousal level alone | No Intervention | • Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) according to the standard clinical practice guidelines for managing pain and agitation for patients receiving mechanical ventilation in the ICU. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titrating sedation targeting both optimal P0.1 and appropriate arousal level | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful extubation within 14 days after randomization | Successful extubation within 14 days without reintubation within 28 days after ICU admission | 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Successful extubation within 7 days after randomization | Successful extubation within 7 days without reintubation within 28 days after ICU admission | 7 days after randomization |
| Successful extubation within 28 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natdanai Ketdao, MD | Contact | +66880684998 | natdke@kku.ac.th | |
| Tanuwong Viarasilpa, MD | Contact | +66813469400 | tanuwong.via@mahidol.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Tanuwong Viarasilpa, MD | Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University | Principal Investigator |
| Natdanai Ketdao, MD | Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Recruiting | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27626833 | Background | Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP. | |
| 37108979 | Background | Sklienka P, Frelich M, Bursa F. Patient Self-Inflicted Lung Injury-A Narrative Review of Pathophysiology, Early Recognition, and Management Options. J Pers Med. 2023 Mar 28;13(4):593. doi: 10.3390/jpm13040593. |
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All IPD that underlie results in a publication of this study (after deidentification)
All IPD will become available starting briefly following a publication of the study with no end date.
Investigators whose proposed use of the data has been approved by institutional review board or ethical committee.
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|
| Fentanyl | Drug | Continuous intravenous infusion of fentanyl 25-75 micrograms/hour |
|
| Midazolam | Drug | Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams/kilogram/hour |
|
| Propofol | Drug | Continuous intravenous infusion of propofol 5 - 50 micrograms/kilogram/minute |
|
| Dexmedetomidine | Drug | Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms/kilogram/hour |
|
| Cisatracurium | Drug | Continuous intravenous infusion of cisatracurium 5 - 20 milligrams/hour |
|
Successful extubation without reintubation within 28 days after ICU admission
| 28 days after randomization |
| Duration of mechanical ventilation | Time from intubation to the last successful extubation | From date of intubation until the date of last successful extubation or date of death from any cause, whichever came first, assessed up to 28 days |
| Ventilator-free days to day 28 after randomization | Number of days alive without mechanical ventilation | 28 days after randomization |
| Reintubation rate at 7 days after randomization | Number of reintubation within 7 days after randomization | 7 days after randomization |
| Self extubation rate at 7 days after extubation | Number of self extubation (accidentally extubation without physician's order) within 7 days after randomization | 7 days after randomization |
| Post-extubation respiratory failure | Patients who meet at least one of the following criteria within 72 hours after extubation: respiratory rate more than 35 breaths/minute, oxygen saturation less than 90% or PaO2 less than 80 mmHg despite receiving FiO2 >50%, respiratory acidosis with pH <7.35 or PaCO2 >50 mmHg or increase of 20% from baseline. | From date of randomization until the date of the first event of post-extubation respiratory failure or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days |
| Tracheostomy | Number of tracheostomy performed | From date of randomization until the date of tracheostomy or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days |
| Lung injury score on day 3 after randomization | Lung injury score on day 3 after randomization | 3 days after randomization |
| Lung injury score on day 7 after randomization | Lung injury score on day 7 after randomization | 7 days after randomization |
| PaO2/FiO2 ratio on day 3 after randomization | PaO2/FiO2 ratio on day 3 after randomization | 3 days after randomization |
| PaO2/FiO2 ratio on day 7 after randomization | PaO2/FiO2 ratio on day 7 after randomization | 7 days after randomization |
| Rates of new diagnosis of ARDS according to the new Berlin criteria after randomization | Number of ARDS diagnoses after randomization | From date of randomization until the date of new onset ARDS diagnosis after randomization or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days |
| Delirium during ICU admission | Delirium assessed by positive CAM-ICU criteria during ICU admission | From date of randomization until the date of diagnosis of delirium diagnosis or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days |
| Glasgow Outcome Scale (GOS) at hospital discharge | Functional status assessed by Glasgow Outcome Scale (GOS) at hospital discharge
| From date of randomization until the date of hospital discharge or date of death from any cause , whichever came first, assessed up to 28 days |
| ICU all-cause mortality | All-cause mortality during ICU admission | From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 days |
| Hospital all-cause mortality | All-cause mortality during hospital admission | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days |
| 28-day mortality after randomization | All-cause mortality during 28-day after randomization | 28 days after randomization |
| ICU length of stay | Time from ICU admission to ICU discharge | From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 days |
| Hospital length of stay | Time from hospital admission to hospital discharge | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days |
| Maximum infusion dose (per hour) of sedation | Maximum infusion dose (per hour) of sedation used during the study period | From date of sedation initiation until the date of sedation discontinuation or date of death from any cause, whichever came first, assessed up to 28 days |
| Duration (days) of sedation | Duration (days) of sedation used during the study period | From date of sedation initiation until the date of sedation discontinuation or date of death from any cause, whichever came first, assessed up to 28 days |
| Ventilator-associated pneumonia | Number of ventilator-associated pneumonia diagnosed after randomization | From date of randomization until the date of first diagnosed ventilator-associated pneumonia or date of death from any cause, whichever came first, assessed up to 28 days |
| Barotrauma | Number of barotrauma (pneumothorax, pneumomediastinum, subcutaneous emphysema) occurred after randomization | From date of randomization until the date of first documented barotrauma or date of death from any cause, whichever came first, assessed up to 28 days |
| Serious adverse events | Number of serious adverse events (severe allergic reaction or anaphylaxis and propofol infusion syndrome defined as severe lactic acidosis and hypertriglyceridemia) occurred after randomization | From date of randomization until the date of first documented serious adverse events or date of death from any cause, whichever came first, assessed up to 28 days |
| Cardiac arrhythmia | Number of cardiac arrhythmia events occurred after randomization | From date of randomization until the date of first documented cardiac arrhythmia events or date of death from any cause, whichever came first, assessed up to 28 days |
| Maximum infusion dose (per hour) of vasopressor | Maximum infusion dose (per hour) of vasopressor used during the study period | From date of vasopressor initiation until the date of vasopressor discontinuation or date of death from any cause, whichever came first, assessed up to 28 days |
| Duration (days) of vasopressor | Duration (days) of vasopressor used during the study period | From date of vasopressor initiation until the date of vasopressor discontinuation or date of death from any cause, whichever came first, assessed up to 28 days |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D016638 | Critical Illness |
| D012128 | Respiratory Distress Syndrome |
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D008874 | Midazolam |
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| C101584 | cisatracurium |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
Not provided
Not provided