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

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

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Delirium on Emergence; Separation

Detailed 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 .

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: xin li, Doctor; Phone Number: 02483283182; Email: xuanfeng7890@163.com
• Study Contact Backup: Name: zhidan zhang, Doctor; Phone Number: 02483283182; Email: zhangzhidan1974@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Yini Sun, Dr; Phone Number: 02483283182; Email: sunyini_106@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients were randomly selected from the ICU of the A tertiary hospitals in the major provinces and cities of China.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium	Incidence of delirium in Chinese ICU patients with analgesia and sedation during the study period	2020.12

Collaborators and Investigators

• Sponsor: China Medical University, China
• Collaborators: Peking University People's Hospital; Qilu Hospital of Shandong University; The First Hospital of Jilin University; The First Affiliated Hospital of Kunming Medical College; General Hospital of Ningxia Medical University; The Second Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Harbin Medical University; The Second Affiliated Hospital of Dalian Medical University; The Second Affiliated Hospital of Kunming Medical University
• Investigators: Study Chair: xiaochun ma, doctor, China Medical University, China

Publications and helpful links

General Publications

• 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.
• 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, Shehabi Y, Skrobik Y, Singh JM, Slooter A, Smith M, Tsuruta R, Latronico N. Worldwide Survey of the "Assessing Pain, Both Spontaneous Awakening and Breathing Trials, Choice of Drugs, Delirium Monitoring/Management, Early Exercise/Mobility, and Family Empowerment" (ABCDEF) Bundle. Crit Care Med. 2017 Nov;45(11):e1111-e1122. doi: 10.1097/CCM.0000000000002640.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 12, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (ACTUAL): January 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: ICU; sedation; analgesia; Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: CMU1h

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No