Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand

Study Overview
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Brief Summary
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The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

Detailed Description
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Pain is frequently reported in patients admitted to an ICU, with an incidence of up to 50% in medical patients during admission, and increasing up to 80% during standard care procedures. Agitation was also reported in 52% of the patients, typically within 4-9 days after admission. However, there were studies reporting inadequate pain, agitation and delirium assessment and management in real-world clinical practice. The clinical practice guideline for the management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU was recently published in 2018 and emphasized routinely monitoring pain, agitation and delirium during ICU admissions. Also, appropriate management of pain and agitation in critically ill patients resulted in reduction in ICU length of stay, hospital length of stay, delirium and mortality. Therefore, structural pain, agitation/sedation, delirium assessment and treatment in the ICUs, Thailand might be necessary. Since pain, agitation/sedation and delirium protocol has not yet been initiated in ICUs, Thailand, this study is designed as a before-after study in order to assess outcomes by comparing between before and after protocol initiation. The objectives of the study were to document the impact of pain, agitation/sedation, delirium protocol on clinical outcomes of ICU patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand

Official Title
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Pain, Agitation, Delirium and Sleep Deprivation Assessment and Management in Intensive Care Units, Thailand: a Before-after Study

Conditions
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Pain, Agitation on Recovery From Sedation, Delirium

Intervention / Treatment
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* Other: PADS protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 years and older) Patients admitted to medical or surgical intensive care units Exclusion Criteria: Terminal ill patients, or patients unlikely to survive > 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A before-after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A Before group<br>No protocol assigned | |
| Experimental: An After group<br>PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned | Other: PADS protocol<br>* Assessment and management per PADS protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU free days | Days alive and not stay in ICU | During ICU stay or death or a maximum of 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilator free days | Day alive and free of mechanical ventilator | During ICU stay or death or a maximum of 28 days | 
| Delirium free days | Day alive and free of delirium | During ICU stay or death or a maximum of 28 days | 
| Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement | Times per patient-days of evaluations during ICU stay | During ICU stay or death or a maximum of 28 days | 
| Incidence of in-target pain, agitation/sedation, delirium | Times per patient-days of in-target pain, agitation/sedation, delirium during ICU stay | During ICU stay or death or a maximum of 28 days | 
| Compliance to PADS protocol | Times per patient-days of PADS protocol use by healthcare providers during ICU stay | During ICU stay or death or a maximum of 28 days | 
| All-cause hospital mortality | Rates of all-cause mortality during hospital stay | During hospital stay or death or a maximum of 90 days | 
| Antipsychotics use | Type and dose of antipsychotics during ICU stay | During ICU stay or death or a maximum of 28 days | 
| Non-benzodiazepines use | Type and dose of non-benzodiazepines during ICU stay | During ICU stay or death or a maximum of 28 days | 
| Benzodiazepines use | Type and dose of non-benzodiazepines during ICU stay | During ICU stay or death or a maximum of 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, agitation, sedation, delirium, protocol