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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Before group | No Intervention | No protocol assigned | |
| An After group | Experimental | PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PADS protocol | Other | Assessment and management per PADS protocol |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Punchika Luetrakool, MD | Ramathibodi hospital, Mahidol university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30113379 | Background | 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. | |
| 23269131 |
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Plan to share individual participant data per request and after 2 years from publications
Two years after publications
Per request to researchers via email
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| ID | Term |
|---|---|
| D010146 | Pain |
| D003693 | Delirium |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
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A before-after study
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| 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 |
| Background |
| 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. |
| 24476433 | Background | 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. |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D011596 | Psychomotor Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |