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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270331
• Other study ID #: MURA2020/151
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation on Recovery From Sedation
• Delirium
• Pain
• Psychomotor Agitation
• Sleep Deprivation

Intervention

Other:
• PADS protocol
Assessment and management per PADS protocol

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas 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. Review. — View Citation

Devlin JW, Skrobik Y, Gélinas 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU free days	Days alive and not stay in ICU	During ICU stay or death or a maximum of 28 days
Secondary	Mechanical ventilator free days	Day alive and free of mechanical ventilator	During ICU stay or death or a maximum of 28 days
Secondary	Delirium free days	Day alive and free of delirium	During ICU stay or death or a maximum of 28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	All-cause hospital mortality	Rates of all-cause mortality during hospital stay	During hospital stay or death or a maximum of 90 days
Secondary	Antipsychotics use	Type and dose of antipsychotics during ICU stay	During ICU stay or death or a maximum of 28 days
Secondary	Non-benzodiazepines use	Type and dose of non-benzodiazepines during ICU stay	During ICU stay or death or a maximum of 28 days
Secondary	Benzodiazepines use	Type and dose of non-benzodiazepines during ICU stay	During ICU stay or death or a maximum of 28 days