Sedation and AnalgesiaEASYNCT04674540
EICU Analgesia and Sedation Cross-sectional Survey
An observational study of Sedation and Analgesia and ICU, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Sedation and analgesia is a very important part of the comprehensive treatment of critically ill patients. The comprehensive management strategy of sedation and analgesia in the Intensive Care Unit (ICU) and the control of infection, the application of antibiotics, and active recovery-are equally important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation and Analgesia, ICU
- How many people
- 1,195 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2018to 26 Jun 2018
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: Any patient older than 18 years admitted to the ICU, in the participating hospitals, will be included in the study
Who may be able to join
- Multiple intensive care units (ICU) and emergency intensive care units (EICU) in China
- Patients older than 18 years in the ICU/EICU
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Investigation on the Cognition and Implementation of Sedation and Analgesia in EICU Critically Ill Patients
Sedation and analgesia is a very important part of the comprehensive treatment of critically ill patients. The comprehensive management strategy of sedation and analgesia in the Intensive Care Unit (ICU) and the control of infection, the application of antibiotics, and active recovery-are equally important. Effective sedation and analgesia assessment tools and reasonable comprehensive management strategies can not only improve patient comfort, reduce discomfort memory, but also reduce nursing workload and improve clinical outcomes. The "eCASH" theory proposed by Vincent et al. in 2016 further improved the comprehensive management strategy for sedation and analgesia. Its main contents are early analgesia to make patients comfortable, minimal sedatives and maximum humanitarian care. However, unreasonable sedation, especially early deep sedation, is closely related to the poor prognosis of patients. With the update of the ICU sedation and analgesia guidelines and the continuous progress of related research, ICU doctors have gradually deepened their understanding of sedation and analgesia. At present, the level of emergency ICU development in various regions of the country is uneven, and the implementation of sedation and analgesia may also vary greatly. Therefore, by investigating and understanding the implementation of emergency ICU or ICU sedation and analgesia in various regions of the country, you can indirectly understand the familiarity of medical staff with sedation and analgesia guidelines, and formulate corresponding strategies for specific situations, which may help improve critical illness. The level of sedation and analgesia of the patient improves the treatment effect.
So far, there are few domestic research reports on the implementation of sedation and analgesia in critical patients, especially the data in the emergency ICU. This study intends to investigate the implementation status of sedation and analgesia in critically ill patients in ICU, to understand the familiarity of medical staff with sedation and analgesia guidelines, and provide a basis for further measures.
Read the detailed description
Part 1: Cognitive survey
Participants: emergency and critical illness medical staff (doctors and nurses) of participating units. The number of medical staff in each unit is at least 12, among which doctors and nurses are ≥6 (the ratio is ≥3 for elementary level and ≥3 for intermediate and above).
Investigate awareness of sedation and analgesia guidelines.
Part 2: Current status of sedation and analgesia
Participants: patients older than 18 years old in the ICU of the participating unit.
- Collect general information of patients that meet the inclusion criteria, including the patient's gender, age, body mass index (BMI), length of stay in ICU (days, with 1 effective decimal), diagnosis, acute physiology and chronicity on day 1 Health status score (Acute Physiology and Chronic Health Evaluation II, APACHE II), whether to receive mechanical ventilation, whether to use vasoconstrictor to maintain blood pressure and other information;
- Assess whether the patients need sedation and analgesia, and divide the patients into groups.
- Sedation assessment: Use the Richmond Sedation and Restlessness Score (RASS score) for sedation assessment. For mechanically ventilated patients, if the RASS score is ≥1, sedation is considered necessary; for patients without mechanical ventilation, if the RASS score is ≥2, consider Sedation is needed; for patients who have been given sedation and the RASS score reaches the target, sedation is also considered necessary.
- Analgesia evaluation: The digital pain scoring method is used for awake patients, and when the score is ≥4 points, the drug is administered according to the WHO three-step analgesic principle; non-conscious patients should use the Critical-Care Pain Observation Tool (CPOT), If CPOT ≥ 3 points, it is considered that there is pain, and analgesia is needed; for patients who are already on analgesia treatment and the pain score reaches the standard, it is also considered that analgesia is needed.
- Evaluation of delirium: Has delirium occurred after entering the ICU? Do you use delirium assessment tools? Record the means of delirium management;
- If sedation and analgesia is required, relevant information will be collected according to the actual situation of each research unit. For patients who do not require sedation and analgesia after the second step assessment, there is no need to collect sedation and analgesia information. This information includes:
- Is there any sedation and analgesia?
- Information about sedation: Are sedation assessment tools used (if used, what kind of sedation assessment tools are used); are sedation target values set (record specific values)? Actual sedation score; name and dose of sedative drugs;
- Analgesia-related information: whether to use analgesia evaluation tools (if used, what analgesia evaluation tools are recorded); whether to set an analgesia target value (record the specific value)? Actual analgesic score; name and dosage of analgesic drugs;
- Conditions
- Sedation and Analgesia, ICU
- Being tested
- No Intervention
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Sedation and Analgesia Implementation Status Group | To investigate the implementation status of sedation and analgesia in ICU critical patients. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition of Sedation and Analgesia
Awareness of sedation and analgesia guidelines. The questionnaire involves 20 questions about the main principles and knowledge of ICU sedation and analgesia treatment.
Measured: 1 day
Sedation assessment: Richmond Agitation and Sedation Scale
Sedation assessment: Richmond Agitation and Sedation Scale (RASS, score from -5 to 4) for sedation assessment.
Measured: 1 day
Analgesia evaluation: The digital pain scoring method
Analgesia evaluation: The digital pain scoring method is used for awake patients (score from 0 to 10);
Measured: 1 day
Analgesia evaluation: Critical-Care Pain Observation Tool
Analgesia evaluation: non-conscious patients should use the Critical-Care Pain Observation Tool (CPOT, score from 0 to 8).
Measured: 1 day
Analgesia evaluation-Confusion Assessment Method of the Intensive Care Unit
Evaluation of delirium: Confusion Assessment Method of the Intensive Care Unit (CAM-ICU) for delirium evaluation.
Measured: 1 day
Secondary outcomes (5)
General information of patients-gender
gender (male or female)
Measured: 1 day
General information of patients-age
Age (older than 18 years )
Measured: 1 day
General information of patients-BMI
height(kg), weight(cm); weight and height will be combined to report BMI in kg/m^2).
Measured: 1 day
General information of patients-length of stay in ICU
length of stay in ICU (day)
Measured: 1 day
General information of patients-APACHE II
Acute Physiology and Chronic Health Evaluation II (APACHE II)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start26 Jun 2018
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,195 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mao Zhang, MD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674540
- Sponsor's protocol ID
- 2018-037
- Acronym
- EASY
- Status last verified
- Dec 2020
- First submitted
- 15 Jun 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need to be approved by the ethics committee
Publications
Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PubMed 23269131Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. doi: 10.1097/01.CCM.0000218416.62457.56.
PubMed 16625136Payen JF, Bosson JL, Chanques G, Mantz J, Labarere J; DOLOREA Investigators. Pain assessment is associated with decreased duration of mechanical ventilation in the intensive care unit: a post Hoc analysis of the DOLOREA study. Anesthesiology. 2009 Dec;111(6):1308-16. doi: 10.1097/ALN.0b013e3181c0d4f0.
PubMed 19934877Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.
PubMed 11902253
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Cognition and Implementation of Sedation and Analgesia in EICU Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04674540
- Acronym / sponsor ID
- EASY / 2018-037
- Conditions
- Sedation and Analgesia, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,195 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 19 Dec 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.
Sedation and analgesia is a very important part of the comprehensive treatment of critically ill patients. The comprehensive management strategy of sedation and analgesia in the Intensive Care Unit (ICU) and the control of infection, the application of antibiotics, and active recovery-are equally important. Effective sedation and analgesia assessment tools and reasonable comprehensive management strategies can not only improve patient comfort, reduce discomfort memory, but also reduce nursing workload and improve clinical outcomes. The "eCASH" theory proposed by Vincent et al. in 2016 further improved the comprehensive management strategy for sedation and analgesia. Its main contents are early analgesia to make patients comfortable, minimal sedatives and maximum humanitarian care. However, unreasonable sedation, especially early deep sedation, is closely related to the poor prognosis of patients. With the update of the ICU sedation and analgesia guidelines and the continuous progress of related research, ICU doctors have gradually deepened their understanding of sedation and analgesia. At present, the level of emergency ICU development in various regions of the country is uneven, and the implementation of sedation and analgesia may also vary greatly. Therefore, by investigating and understanding the implementation of emergency ICU or ICU sedation and analgesia in various regions of the country, you can indirectly understand the familiarity of medical staff with sedation and analgesia guidelines, and formulate corresponding strategies for specific situations, which may help improve critical illness. The level of sedation and analgesia of the patient improves the treatment effect.
So far, there are few domestic research reports on the implementation of sedation and analgesia in critical patients, especially the data in the emergency ICU. This study intends to investigate the implementation status of sedation and analgesia in critically ill patients in ICU, to understand the familiarity of medical staff with sedation and analgesia guidelines, and provide a basis for further measures.
Detailed description
Part 1: Cognitive survey
Participants: emergency and critical illness medical staff (doctors and nurses) of participating units. The number of medical staff in each unit is at least 12, among which doctors and nurses are ≥6 (the ratio is ≥3 for elementary level and ≥3 for intermediate and above).
Investigate awareness of sedation and analgesia guidelines.
Part 2: Current status of sedation and analgesia
Participants: patients older than 18 years old in the ICU of the participating unit.
- Collect general information of patients that meet the inclusion criteria, including the patient's gender, age, body mass index (BMI), length of stay in ICU (days, with 1 effective decimal), diagnosis, acute physiology and chronicity on day 1 Health status score (Acute Physiology and Chronic Health Evaluation II, APACHE II), whether to receive mechanical ventilation, whether to use vasoconstrictor to maintain blood pressure and other information;
- Assess whether the patients need sedation and analgesia, and divide the patients into groups.
- Sedation assessment: Use the Richmond Sedation and Restlessness Score (RASS score) for sedation assessment. For mechanically ventilated patients, if the RASS score is ≥1, sedation is considered necessary; for patients without mechanical ventilation, if the RASS score is ≥2, consider Sedation is needed; for patients who have been given sedation and the RASS score reaches the target, sedation is also considered necessary.
- Analgesia evaluation: The digital pain scoring method is used for awake patients, and when the score is ≥4 points, the drug is administered according to the WHO three-step analgesic principle; non-conscious patients should use the Critical-Care Pain Observation Tool (CPOT), If CPOT ≥ 3 points, it is considered that there is pain, and analgesia is needed; for patients who are already on analgesia treatment and the pain score reaches the standard, it is also considered that analgesia is needed.
- Evaluation of delirium: Has delirium occurred after entering the ICU? Do you use delirium assessment tools? Record the means of delirium management;
- If sedation and analgesia is required, relevant information will be collected according to the actual situation of each research unit. For patients who do not require sedation and analgesia after the second step assessment, there is no need to collect sedation and analgesia information. This information includes:
- Is there any sedation and analgesia?
- Information about sedation: Are sedation assessment tools used (if used, what kind of sedation assessment tools are used); are sedation target values set (record specific values)? Actual sedation score; name and dose of sedative drugs;
- Analgesia-related information: whether to use analgesia evaluation tools (if used, what analgesia evaluation tools are recorded); whether to set an analgesia target value (record the specific value)? Actual analgesic score; name and dosage of analgesic drugs;
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sedation and Analgesia Implementation Status Group | – | Other: No InterventionTo investigate the implementation status of sedation and analgesia in ICU critical patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patient older than 18 years admitted to the ICU, in the participating hospitals, will be included in the study
Key inclusion criteria (2 listed)
- Multiple intensive care units (ICU) and emergency intensive care units (EICU) in China
- Patients older than 18 years in the ICU/EICU
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Sedation and Analgesia Implementation Status Group |
Primary outcome
Cognition of Sedation and Analgesia
Time frame: 1 day
Awareness of sedation and analgesia guidelines. The questionnaire involves 20 questions about the main principles and knowledge of ICU sedation and analgesia treatment.
Sedation assessment: Richmond Agitation and Sedation Scale
Time frame: 1 day
Sedation assessment: Richmond Agitation and Sedation Scale (RASS, score from -5 to 4) for sedation assessment.
Analgesia evaluation: The digital pain scoring method
Time frame: 1 day
Analgesia evaluation: The digital pain scoring method is used for awake patients (score from 0 to 10);
Analgesia evaluation: Critical-Care Pain Observation Tool
Time frame: 1 day
Analgesia evaluation: non-conscious patients should use the Critical-Care Pain Observation Tool (CPOT, score from 0 to 8).
Analgesia evaluation-Confusion Assessment Method of the Intensive Care Unit
Time frame: 1 day
Evaluation of delirium: Confusion Assessment Method of the Intensive Care Unit (CAM-ICU) for delirium evaluation.
5 secondary outcomes
General information of patients-gender
Time frame: 1 day
General information of patients-age
Time frame: 1 day
General information of patients-BMI
Time frame: 1 day
General information of patients-length of stay in ICU
Time frame: 1 day
General information of patients-APACHE II
Time frame: 1 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 19 Dec 2020.
- Background: PubMed 23269131Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
- Background: PubMed 16625136Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. doi: 10.1097/01.CCM.0000218416.62457.56.
- Background: PubMed 19934877Payen JF, Bosson JL, Chanques G, Mantz J, Labarere J; DOLOREA Investigators. Pain assessment is associated with decreased duration of mechanical ventilation in the intensive care unit: a post Hoc analysis of the DOLOREA study. Anesthesiology. 2009 Dec;111(6):1308-16. doi: 10.1097/ALN.0b013e3181c0d4f0.
- Background: PubMed 11902253Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.
- Individual participant dataSharing planned: Undecided. Need to be approved by the ethics committee
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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.
Mao Zhang, MD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Sedation and Analgesia and ICU, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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 19 Dec 2020. 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?
Cognition of Sedation and Analgesia (time frame: 1 day). The study lists 5 primary outcomes in all. 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 NCT04674540, which also lists 4 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 19 Dec 2020.