A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China

Analgesia Clinical Trial

— SASE  

Official title:

A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217915
• Other study ID #: CMU1h
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: China Medical University, China
• Contact: xin li, Doctor
• Phone: 02483283182
• Email: xuanfeng7890[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In 2018, the severe medicine branch of the Chinese Medical Association and the American Society of severe medicine successively updated the pain and sedation guidelines for severe patients (PADIS guidelines). In addition to the update of the original evaluation and management of pain and sedation and delirium, the new guidelines also increased the monitoring and management of early activities and sleep quality for severe patients. Therefore, it is necessary for us to investigate the compliance of the new guidelines for analgesia, sedation and delirium management among the medical staff of critical care, so as to find out the existing problems in the management of analgesia, sedation and delirium in critical care patients, and find solutions to improve the overall quality level of our management of critical care patients

Description:

The first part is to master the current situation of analgesia, sedation and delirium management of ICU patients in China. In order to understand the compliance of Chinese ICU doctors and nurses with the PADIS guidelines, a questionnaire survey was conducted with the participation of multiple centers in China, aiming at the doctors and nurses with different seniority in the critical medicine department. At the same time, the total number of critically ill patients, pain, agitation and delirium assessment tools and critical patients in 2018 were investigated The incidence of pain, agitation and delirium, the implementation of early activities, the monitoring and evaluation of sleep quality, and related interventions, including real-world clinical data such as drug treatment and non drug treatment.The second part focuses on the management of severe delirium in ICU in China. For the patients with delirium in the above survey, a further in-depth and detailed survey shall be conducted, covering the basic diseases of the patients, the occurrence time of delirium, the type of delirium, relevant risk factors, the diagnosis method of delirium, the duration of delirium, the prevention and treatment measures (including drug treatment and non drug treatment measures), and the prognosis of delirium patients .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old;

• stay in ICU for more than 24 hours and have used analgesics and Sedatives.

Exclusion Criteria:

• Before entering the ICU, they had mental illness and dementia;

• coma or deep sedation could not be evaluated;

• brain injury, stroke sequelae, epilepsy and other brain diseases;

• nerious audio-visual dysfunction and unable to communicate normally.

• Pregnant and lactating women

Related Conditions & MeSH terms

• Analgesia
• Delirium
• Delirium on Emergence
• Emergence Delirium
• Separation

Locations

Country	Name	City	State
China	the first hospital of China Medical University	Shenyang	Liaoning

Sponsors (11)

Lead Sponsor

Collaborator

China Medical University, China

First Affiliated Hospital of Harbin Medical University, General Hospital of Ningxia Medical University, Peking University People's Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Kunming Medical College, The First Hospital of Jilin University, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Morandi A, Piva S, Ely EW, Myatra SN, Salluh JIF, Amare D, Azoulay E, Bellelli G, Csomos A, Fan E, Fagoni N, Girard TD, Heras La Calle G, Inoue S, Lim CM, Kaps R, Kotfis K, Koh Y, Misango D, Pandharipande PP, Permpikul C, Cheng Tan C, Wang DX, Sharshar T, — View Citation

Wang J, Peng ZY, Zhou WH, Hu B, Rao X, Li JG. A National Multicenter Survey on Management of Pain, Agitation, and Delirium in Intensive Care Units in China. Chin Med J (Engl). 2017 May 20;130(10):1182-1188. doi: 10.4103/0366-6999.205852. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance of ICU medical staff with PADIS guidelines	The assessment tool is a self-designed questionnaire based on the guidelines, which is mainly used to assess the compliance of medical staff with the guidelines in their daily work	2020.12
Secondary	Incidence of delirium	Incidence of delirium in Chinese ICU patients with analgesia and sedation during the study period	2020.12