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NCT Number: NCT04674540

EICU Analgesia and Sedation Cross-sectional Survey

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

About this study

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;

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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);

  4. 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).

  5. 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.

Secondary outcomes

  1. General information of patients-gender

    Time frame: 1 day

    gender (male or female)

  2. General information of patients-age

    Time frame: 1 day

    Age (older than 18 years )

  3. General information of patients-BMI

    Time frame: 1 day

    height(kg), weight(cm); weight and height will be combined to report BMI in kg/m^2).

  4. General information of patients-length of stay in ICU

    Time frame: 1 day

    length of stay in ICU (day)

  5. General information of patients-APACHE II

    Time frame: 1 day

    Acute Physiology and Chronic Health Evaluation II (APACHE II)

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Investigation on the Cognition and Implementation of Sedation and Analgesia in EICU Critically Ill Patients

Acronym: EASY

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2020
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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