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

NCT04217915 | Unknown DMC

• 1 other identifier: CMU1h
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Delirium on Emergence; Analgesia; Separation

Keywords

analgesia; sedation; ICU; Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of delirium

  2020.12

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years old;
• stay in ICU for more than 24 hours and have used analgesics and Sedatives.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Peking University People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First Hospital of Jilin University: collaborator
• General Hospital of Ningxia Medical University: collaborator

Study Sites (1)

the first hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 28485318 RESULT

• 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.

  PMID: 28787293 RESULT

MeSH Terms

Conditions

Emergence Delirium; Agnosia; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Perceptual Disorders

Study Officials

• xiaochun ma, doctor

  China Medical University, China

  STUDY CHAIR

Central Study Contacts

xin li, Doctor

CONTACT

02483283182; xuanfeng7890@163.com

zhidan zhang, Doctor

CONTACT

02483283182; zhangzhidan1974@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of ICUof first hospital of China medical university

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 6, 2020
• Study Start: July 12, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)