Management of PADIS in Emergency Intensive Care Unit

Pain Clinical Trial

Official title:

Management of Pain, Agitation-sedation, Delirium Immobility and Sleep Disruption in Emergency Intensive Care Unit: a Multicenter Cross-sectional Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06339385
• Other study ID #: KY 2020-153-02
• Status: Completed
• Start date: June 13, 2021
• Est. completion date: August 12, 2021

Study information

• Verified date: March 2024
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS. The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients' enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted to the participating EDICU during the on-site investigation

Exclusion Criteria:

• Age less than 18 years;
• EDICU stay duration before the screening was less than 24 hours
• Enrollment in other concurrent trials.

Related Conditions & MeSH terms

• Agitation, Emergence
• Critical Illness
• Delirium
• Emergence Delirium
• Emergencies
• Pain
• Psychomotor Agitation

Intervention

Behavioral:
• PADIS assessment
Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium.

Locations

Country	Name	City	State
China	Beijing Tiantan hospital	Beijing	Beijing

Sponsors (16)

Lead Sponsor

Collaborator

Capital Medical University

Affiliated hospital of Guilin medical university,China, Beijing Anzhen Hospital, Beijing Tiantan Hospital, Fudan University, General hospital of shenyang military command, Mianyang Central Hospital, Southwest Hospital, China, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Hebei Medical University, The First Hospital of Jilin University, The Jiangxi Provincial People's Hospital, The Second Affiliated Hospital of Hainan Medical University, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PADIS assessment rate		24 hours before enrollment
Secondary	Rates of analgesic and sedative administration		24 hours before enrollment
Secondary	Rate of accidental removal of the catheter during the EICU stay		From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
Secondary	EDICU length of stay		From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
Secondary	The hospital length of stay		From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.