PainNCT06339385
Management of PADIS in Emergency Intensive Care Unit
An observational study of Pain and Agitation, Emergence, run by Capital Medical University at 1 site in China.
Trial summary
Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS. The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Agitation, Emergence, Delirium
- What is being tested?
- PADIS assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2021to 12 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the participating EDICU during the on-site investigation were eligible for enrollment in this study. However, patients meeting the following criteria were excluded: 1) age less than 18 years; 2) EDICU stay duration before the screening was less than 24 hours; 3) enrollment in other concurrent trials.
Who may be able to join
- All patients admitted to the participating EDICU during the on-site investigation
Who cannot join
- Age less than 18 years;
- EDICU stay duration before the screening was less than 24 hours
- Enrollment in other concurrent trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Pain, Agitation-sedation, Delirium Immobility and Sleep Disruption in Emergency Intensive Care Unit: a Multicenter Cross-sectional Survey
Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS.
The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients\' enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices.
- Conditions
- Pain, Agitation, Emergence, Delirium, Critical Illness
- Being tested
- PADIS assessment
- Keywords
- Emergency Department Intensive Care Units, Prevalence, Survey, Practices
- Medical subject headings
- Pain, Emergence Delirium, Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PADIS assessmentBehavioural
Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium.
| Study group | Role | What they receive |
|---|---|---|
| EDICU patients | All patients admitted to the participating EDICU during the on-site investigation. Receives: Behavioral: PADIS assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PADIS assessment rate
Measured: 24 hours before enrollment
Secondary outcomes (4)
Rates of analgesic and sedative administration
Measured: 24 hours before enrollment
Rate of accidental removal of the catheter during the EICU stay
Measured: From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
EDICU length of stay
Measured: From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
The hospital length of stay
Measured: From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start13 Jun 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, Fudan University, Guilin Medical University, China, The Second Affiliated Hospital of Hainan Medical University, The First Hospital of Hebei Medical University, The First Hospital of Jilin University, Southwest Hospital, China, General Hospital of Shenyang Military Region, Beijing Anzhen Hospital, Mianyang Central Hospital, Tianjin Medical University General Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangxi Provincial People's Hopital
- Responsible party
- Principal investigator, Zhou Yi-Min, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339385
- Sponsor's protocol ID
- KY 2020-153-02
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pain, Agitation-sedation, Delirium Immobility and Sleep Disruption in Emergency Intensive Care Unit: a Multicenter Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT06339385
- Acronym / sponsor ID
- KY 2020-153-02
- Conditions
- Pain, Agitation, Emergence, Delirium, Critical Illness
- Keywords
- Emergency Department Intensive Care Units, Prevalence, Survey, Practices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, Fudan University, Guilin Medical University, China, The Second Affiliated Hospital of Hainan Medical University, The First Hospital of Hebei Medical University, The First Hospital of Jilin University, Southwest Hospital, China, General Hospital of Shenyang Military Region, Beijing Anzhen Hospital, Mianyang Central Hospital, Tianjin Medical University General Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangxi Provincial People's Hopital
- Study start
- 13 Jun 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 1 Apr 2024 (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.
Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS.
The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients\' enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDICU patients | – | Behavioral: PADIS assessmentAll patients admitted to the participating EDICU during the on-site investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the participating EDICU during the on-site investigation were eligible for enrollment in this study. However, patients meeting the following criteria were excluded: 1) age less than 18 years; 2) EDICU stay duration before the screening was less than 24 hours; 3) enrollment in other concurrent trials.
Key inclusion criteria (1 listed)
- All patients admitted to the participating EDICU during the on-site investigation
Key exclusion criteria (3 listed)
- Age less than 18 years;
- EDICU stay duration before the screening was less than 24 hours
- Enrollment in other concurrent trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PADIS assessmentHospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. | Behavioural | EDICU patients |
Primary outcome
PADIS assessment rate
Time frame: 24 hours before enrollment
4 secondary outcomes
Rates of analgesic and sedative administration
Time frame: 24 hours before enrollment
Rate of accidental removal of the catheter during the EICU stay
Time frame: From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
EDICU length of stay
Time frame: From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
The hospital length of stay
Time frame: From the start of the survey day until transfer out of the EDICU or 60 days after the survey day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain and Agitation, Emergence, run by Capital Medical University 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PADIS assessment rate (time frame: 24 hours before enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.