Clinical trial NCT04270331: Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand
Official title: Pain, Agitation, Delirium and Sleep Deprivation Assessment and Management in Intensive Care Units, Thailand: a Before-after Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Agitation on Recovery From Sedation
Delirium
Keywords: pain
agitation
sedation
delirium
protocol
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A before-after study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: ICU free days
timeFrame: During ICU stay or death or a maximum of 28 days
Secondary outcomes:
measure: Mechanical ventilator free days
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Delirium free days
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Incidence of in-target pain, agitation/sedation, delirium
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Compliance to PADS protocol
timeFrame: During ICU stay or death or a maximum of 28 days
measure: All-cause hospital mortality
timeFrame: During hospital stay or death or a maximum of 90 days
measure: Antipsychotics use
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Non-benzodiazepines use
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Benzodiazepines use
timeFrame: During ICU stay or death or a maximum of 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Ramathibodi hospital, Mahidol university
name: Punchika Luetrakool, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. No abstract available.