EICU Analgesia and Sedation Cross-sectional Survey (EASY)

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.

Study Overview

• Status: Completed
• Conditions: ICU; Sedation and Analgesia
• Intervention / Treatment: Other: No Intervention

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;

• Study Type: Observational
• Enrollment (Actual): 1195

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sedation and Analgesia Implementation Status Group; To investigate the implementation status of sedation and analgesia in ICU critical patients.	Other: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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);	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).	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General information of patients-gender	gender (male or female)	1 day
General information of patients-age	Age (older than 18 years )	1 day
General information of patients-BMI	height(kg), weight(cm); weight and height will be combined to report BMI in kg/m^2).	1 day
General information of patients-length of stay in ICU	length of stay in ICU (day)	1 day
General information of patients-APACHE II	Acute Physiology and Chronic Health Evaluation II (APACHE II)	1 day

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Crit Care Med 2002 Mar;30(3):726.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): June 26, 2018
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 2018-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Need to be approved by the ethics committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No