NCT04674540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,195

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

Same day

First QC Date

June 15, 2020

Last Update Submit

December 16, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • General information of patients-gender

    1 day

  • General information of patients-age

    1 day

  • General information of patients-BMI

    1 day

  • General information of patients-length of stay in ICU

    1 day

  • General information of patients-APACHE II

    1 day

Study Arms (1)

Sedation and Analgesia Implementation Status Group

To investigate the implementation status of sedation and analgesia in ICU critical patients.

Other: No Intervention

Interventions

No Intervention

Sedation and Analgesia Implementation Status Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient older than 18 years admitted to the ICU, in the participating hospitals, will be included in the study

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (4)

  • 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.

    PMID: 23269131BACKGROUND
  • 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.

    PMID: 16625136BACKGROUND
  • 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.

    PMID: 19934877BACKGROUND
  • 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.

    PMID: 11902253BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mao Zhang, MD

    Second Affiliated Hospital, Zhejiang University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

December 19, 2020

Study Start

June 26, 2018

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

December 19, 2020

Record last verified: 2020-12

Locations