Delirium on EmergenceSASENCT04217915
A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China
An observational study of Delirium on Emergence and Analgesia, run by China Medical University, China at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Delirium on Emergence, Analgesia, Separation
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were randomly selected from the ICU of the A tertiary hospitals in the major provinces and cities of China.
Who may be able to join
- Age ≥ 18 years old;
- stay in ICU for more than 24 hours and have used analgesics and Sedatives.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first hospital of China Medical University
Shenyang, Liaoning, 110001
Yini Sun, Dr, 02483283182, sunyini_106@163.com
About this study
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
Read the 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 .
- Conditions
- Delirium on Emergence, Analgesia, Separation
- Keywords
- analgesia, sedation, ICU, Delirium
- Medical subject headings
- Emergence Delirium, Agnosia, Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2020.12
Secondary outcomes (1)
Incidence of delirium
Incidence of delirium in Chinese ICU patients with analgesia and sedation during the study period
Measured: 2020.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start12 Jul 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delirium on EmergenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Kunming Medical University, 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, The First Hospital of Jilin University, General Hospital of Ningxia Medical University
- Responsible party
- Principal investigator, Xiaochun Ma,MD, China Medical University, China
- Investigators
- xiaochun ma, doctor, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217915
- Sponsor's protocol ID
- CMU1h
- Acronym
- SASE
- Status last verified
- Jul 2021
- First submitted
- 30 Dec 2019
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28485318Morandi 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.
PubMed 28787293
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China
- ClinicalTrials.gov ID
- NCT04217915
- Acronym / sponsor ID
- SASE / CMU1h
- Conditions
- Delirium on Emergence, Analgesia, Separation
- Keywords
- analgesia, sedation, ICU, Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Kunming Medical University, 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, The First Hospital of Jilin University, General Hospital of Ningxia Medical University
- Study start
- 12 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were randomly selected from the ICU of the A tertiary hospitals in the major provinces and cities of China.
Key inclusion criteria (2 listed)
- Age ≥ 18 years old;
- stay in ICU for more than 24 hours and have used analgesics and Sedatives.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Incidence of delirium
Time frame: 2020.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Results publication: PubMed 28485318Wang 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.
- Results publication: PubMed 28787293Morandi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaochun ma, doctor study chair
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium on Emergence and Analgesia, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xin li, Doctor (02483283182, xuanfeng7890@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of ICU medical staff with PADIS guidelines (time frame: 2020.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.