Clinical trial NCT04674540: EICU Analgesia and Sedation Cross-sectional Survey
Official title: Investigation on the Cognition and Implementation of Sedation and Analgesia in EICU Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation and Analgesia
ICU
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 1195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient older than 18 years admitted to the ICU, in the participating hospitals, will be included in the study

Brief 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. 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.

1. 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;

2. Assess whether the patients need sedation and analgesia, and divide the patients into groups.

1. 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.
2. 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.
3. Evaluation of delirium: Has delirium occurred after entering the ICU? Do you use delirium assessment tools? Record the means of delirium management;

3. 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:

1. Is there any sedation and analgesia?
2. 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;
3. 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;

Eligibility criteria: Inclusion Criteria:

* Multiple intensive care units (ICU) and emergency intensive care units (EICU) in China
* Patients older than 18 years in the ICU/EICU

Exclusion Criteria:

* None

Primary outcomes:
measure: Cognition of Sedation and Analgesia
timeFrame: 1 day
measure: Sedation assessment: Richmond Agitation and Sedation Scale
timeFrame: 1 day
measure: Analgesia evaluation: The digital pain scoring method
timeFrame: 1 day
measure: Analgesia evaluation: Critical-Care Pain Observation Tool
timeFrame: 1 day
measure: Analgesia evaluation-Confusion Assessment Method of the Intensive Care Unit
timeFrame: 1 day
Secondary outcomes:
measure: General information of patients-gender
timeFrame: 1 day
measure: General information of patients-age
timeFrame: 1 day
measure: General information of patients-BMI
timeFrame: 1 day
measure: General information of patients-length of stay in ICU
timeFrame: 1 day
measure: General information of patients-APACHE II
timeFrame: 1 day
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
name: Mao Zhang, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Chanques 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.
citation: Payen 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.
citation: Jacobi 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.