Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203405
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-07
Brief Title:
The Efficacy of P01-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation A Randomized Controlled Trial
Sponsor:
Siriraj Hospital
Organization:
Siriraj Hospital
Study Overview
Official Title:
The Efficacy of P01-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P01 and arousal level compared with conventional sedation strategy targeting arousal level alone in patients requiring mechanical ventilation in the medical intensive care unit
Detailed Description:
Objective to assess the efficacy of sedation protocol targeting optimal respiratory drive using P01 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 P01 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 11 ratio and allocated to each study group intervention and control group
After allocation patients will be monitored for arousal level using RASS score and respiratory drive by P01 measured automatically from mechanical ventilators during the study period
Sedation and neuromuscular blocking agents used will be adjusted according to the group to which patients are allocated
Intervention group Adjustment of sedation and neuromuscular blocking agents to achieve the target of light sedation RASS 0 to -2 and optimal P01 15 to 35 cmH2O for 48 hours
Control group Adjustment of sedation to achieve the target of light sedation RASS 0 to -2 alone for 48 hours
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
The main questions it aims to answer are
Will titration of sedation targeting optimal respiratory drive assessed by P01 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 11 ratio and allocated to each study group intervention and control group
After allocation patients will be monitored for arousal level using RASS score and respiratory drive by P01 measured automatically from mechanical ventilators during the study period
Sedation and neuromuscular blocking agents used will be adjusted according to the group to which patients are allocated
Intervention group Adjustment of sedation and neuromuscular blocking agents to achieve the target of light sedation RASS 0 to -2 and optimal P01 15 to 35 cmH2O for 48 hours
Control group Adjustment of sedation to achieve the target of light sedation RASS 0 to -2 alone for 48 hours
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None