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Completed

NCT Number: NCT04270331

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PADS protocol

Other

Assessment and management per PADS protocol

Primary outcomes

  1. ICU free days

    Time frame: During ICU stay or death or a maximum of 28 days

    Days alive and not stay in ICU

Secondary outcomes

  1. Mechanical ventilator free days

    Time frame: During ICU stay or death or a maximum of 28 days

    Day alive and free of mechanical ventilator

  2. Delirium free days

    Time frame: During ICU stay or death or a maximum of 28 days

    Day alive and free of delirium

  3. Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement

    Time frame: During ICU stay or death or a maximum of 28 days

    Times per patient-days of evaluations during ICU stay

  4. Incidence of in-target pain, agitation/sedation, delirium

    Time frame: During ICU stay or death or a maximum of 28 days

    Times per patient-days of in-target pain, agitation/sedation, delirium during ICU stay

  5. Compliance to PADS protocol

    Time frame: During ICU stay or death or a maximum of 28 days

    Times per patient-days of PADS protocol use by healthcare providers during ICU stay

  6. All-cause hospital mortality

    Time frame: During hospital stay or death or a maximum of 90 days

    Rates of all-cause mortality during hospital stay

  7. Antipsychotics use

    Time frame: During ICU stay or death or a maximum of 28 days

    Type and dose of antipsychotics during ICU stay

  8. Non-benzodiazepines use

    Time frame: During ICU stay or death or a maximum of 28 days

    Type and dose of non-benzodiazepines during ICU stay

  9. Benzodiazepines use

    Time frame: During ICU stay or death or a maximum of 28 days

    Type and dose of non-benzodiazepines during ICU stay

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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