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

Not Applicable

Completed

• Conditions: Agitation on Recovery From Sedation; Delirium; Pain
• Interventions: Other: PADS protocol

• Registration Number: NCT04270331
• Lead Sponsor: Mahidol University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Study Start: 2020-04-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
An After group	PADS protocol	PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned

Primary Outcome Measures

Name	Time	Method
ICU free days	During ICU stay or death or a maximum of 28 days	Days alive and not stay in ICU

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand