Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand
Primary Purpose
Pain, Agitation on Recovery From Sedation, Delirium
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
PADS protocol
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring pain, agitation, sedation, delirium, protocol
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
Sites / Locations
- Ramathibodi Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
A Before group
An After group
Arm Description
No protocol assigned
PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned
Outcomes
Primary Outcome Measures
ICU free days
Days alive and not stay in ICU
Secondary Outcome Measures
Mechanical ventilator free days
Day alive and free of mechanical ventilator
Delirium free days
Day alive and free of delirium
Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement
Times per patient-days of evaluations during ICU stay
Incidence of in-target pain, agitation/sedation, delirium
Times per patient-days of in-target pain, agitation/sedation, delirium during ICU stay
Compliance to PADS protocol
Times per patient-days of PADS protocol use by healthcare providers during ICU stay
All-cause hospital mortality
Rates of all-cause mortality during hospital stay
Antipsychotics use
Type and dose of antipsychotics during ICU stay
Non-benzodiazepines use
Type and dose of non-benzodiazepines during ICU stay
Benzodiazepines use
Type and dose of non-benzodiazepines during ICU stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04270331
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Agitation on Recovery From Sedation, Delirium
Keywords
pain, agitation, sedation, delirium, protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A before-after study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
509 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Before group
Arm Type
No Intervention
Arm Description
No protocol assigned
Arm Title
An After group
Arm Type
Experimental
Arm Description
PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned
Intervention Type
Other
Intervention Name(s)
PADS protocol
Intervention Description
Assessment and management per PADS protocol
Primary Outcome Measure Information:
Title
ICU free days
Description
Days alive and not stay in ICU
Time Frame
During ICU stay or death or a maximum of 28 days
Secondary Outcome Measure Information:
Title
Mechanical ventilator free days
Description
Day alive and free of mechanical ventilator
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Delirium free days
Description
Day alive and free of delirium
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement
Description
Times per patient-days of evaluations during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Incidence of in-target pain, agitation/sedation, delirium
Description
Times per patient-days of in-target pain, agitation/sedation, delirium during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Compliance to PADS protocol
Description
Times per patient-days of PADS protocol use by healthcare providers during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
All-cause hospital mortality
Description
Rates of all-cause mortality during hospital stay
Time Frame
During hospital stay or death or a maximum of 90 days
Title
Antipsychotics use
Description
Type and dose of antipsychotics during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Non-benzodiazepines use
Description
Type and dose of non-benzodiazepines during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Benzodiazepines use
Description
Type and dose of non-benzodiazepines during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punchika Luetrakool, MD
Organizational Affiliation
Ramathibodi hospital, Mahidol university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30113379
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.
Results Reference
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PubMed Identifier
23269131
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.
Results Reference
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PubMed Identifier
24476433
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.
Results Reference
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Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand
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