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

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ClinicalTrials.gov Identifier: NCT04217915
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
The Second Affiliated Hospital of Kunming Medical University
The First Affiliated Hospital of Kunming Medical College
First Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital of Dalian Medical University
Peking University People's Hospital
Qilu Hospital of Shandong University
The Second Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Harbin Medical University
First Hospital of Jilin University
General Hospital of Ningxia Medical University
Information provided by (Responsible Party):
Xiaochun Ma,MD, China Medical University, China

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

Condition or disease
Delirium on Emergence Analgesia 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 .

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Compliance of ICU medical staff with PADIS guidelines [ Time Frame: 2020.12 ]
    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


Secondary Outcome Measures :
  1. Incidence of delirium [ Time Frame: 2020.12 ]
    Incidence of delirium in Chinese ICU patients with analgesia and sedation during the study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217915


Contacts
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Contact: xin li, Doctor 02483283182 xuanfeng7890@163.com
Contact: zhidan zhang, Doctor 02483283182 zhangzhidan1974@163.com

Sponsors and Collaborators
China Medical University, China
The Second Affiliated Hospital of Kunming Medical University
The First Affiliated Hospital of Kunming Medical College
First Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital of Dalian Medical University
Peking University People's Hospital
Qilu Hospital of Shandong University
The Second Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Harbin Medical University
First Hospital of Jilin University
General Hospital of Ningxia Medical University
Investigators
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Study Chair: xiaochun ma, doctor China Medical University, China
Publications of Results:
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Responsible Party: Xiaochun Ma,MD, director of ICUof first hospital of China medical university, China Medical University, China
ClinicalTrials.gov Identifier: NCT04217915    
Other Study ID Numbers: CMU1h
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaochun Ma,MD, China Medical University, China:
analgesia
sedation
ICU
Delirium
Additional relevant MeSH terms:
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Agnosia
Delirium
Emergence Delirium
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Confusion
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes