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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Delirium; Agitation on Recovery From Sedation
• Intervention / Treatment: Other: PADS protocol

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 Type: Interventional
• Enrollment (Actual): 509
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Punchika Luetrakool, MD, Ramathibodi Hospital, Mahidol University

Publications and helpful links

General Publications

• Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.
• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
• Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pain; delirium; agitation; sedation; protocol
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Sleep Deprivation
• Other Study ID Numbers: MURA2020/151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Plan to share individual participant data per request and after 2 years from publications
• IPD Sharing Time Frame: Two years after publications
• IPD Sharing Access Criteria: Per request to researchers via email
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No