NCT04270331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

February 12, 2020

Last Update Submit

August 30, 2021

Conditions

PainAgitation on Recovery From SedationDelirium

Keywords

painagitationsedationdeliriumprotocol

Outcome Measures

Primary Outcomes (1)

  • ICU free days

    Days alive and not stay in ICU

    During ICU stay or death or a maximum of 28 days

Secondary Outcomes (9)

  • Mechanical ventilator free days

    During ICU stay or death or a maximum of 28 days

  • Delirium free days

    During ICU stay or death or a maximum of 28 days

  • Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement

    During ICU stay or death or a maximum of 28 days

  • Incidence of in-target pain, agitation/sedation, delirium

    During ICU stay or death or a maximum of 28 days

  • Compliance to PADS protocol

    During ICU stay or death or a maximum of 28 days

  • +4 more secondary outcomes

Study Arms (2)

A Before group

NO INTERVENTION

No protocol assigned

An After group

EXPERIMENTAL

PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned

Other: PADS protocol

Interventions

PADS protocolOTHER

Assessment and management per PADS protocol

An After group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 years and older)
  • Patients admitted to medical or surgical intensive care units

You may not qualify if:

  • Terminal ill patients, or patients unlikely to survive \> 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (3)

  • 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.

    PMID: 30113379BACKGROUND

  • 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.

    PMID: 23269131BACKGROUND

  • 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.

    PMID: 24476433BACKGROUND

MeSH Terms

Conditions

PainDeliriumPsychomotor Agitation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsConfusionNeurobehavioral ManifestationsNervous System DiseasesNeurocognitive DisordersMental DisordersDyskinesiasPsychomotor DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Punchika Luetrakool, MD

    Ramathibodi hospital, Mahidol university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: A before-after study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

April 1, 2020

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Plan to share individual participant data per request and after 2 years from publications

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Two years after publications
Access Criteria
Per request to researchers via email

Locations

TH(1)