NCT05564975

Brief Summary

In the previous investigation, investigators found that when the risk factors of stress injury in critical patients changed, clinical nurses lacked the awareness of evaluating the risk of stress injury, and lacked the risk assessment of this link. The stress risk prediction model is based on etiology. By analyzing the risk factors, the machine learning algorithm is used to evaluate the risk of pressure damage, and the prediction model of pressure damage can dynamically and comprehensively evaluate its risk. It is also a risk assessment tool. At present, there is no research on applying the stress injury risk prediction model of critical patients to the intensive care information software in China. In this study, the artificial intelligence algorithm library will be used to construct and apply the stress injury risk prediction model for critical patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

September 29, 2022

Last Update Submit

October 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital-acquired pressure injury

    The staging assessment of pressure injuries was based on the 2016 edition of the American Pressure Injury Expert Advisory Group Guidelines(WOCN 2016 Guideline).

    2023-03-01

Study Arms (2)

Hospital-acquired pressure injury group

According to the hospital adverse event management system, patients diagnosed with pressure injury in the hospital were included in the HAPI group, and patients who reported high risk of pressure injury during the same period were selected and included in the non-HAPI group.

No-hospital-acquired pressure injury group

According to the hospital adverse event management system, patients diagnosed with pressure injury in the hospital were included in the HAPI group, and patients who reported high risk of pressure injury during the same period were selected and included in the non-HAPI group.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients This study was a retrospective study, and all patients meeting the admission criteria were selected from the Intensive Care Unit (ICU) of a tertiary comprehensive university-affiliated hospital from January 2016 to December 2021 (34 beds were provided for critical care, and 2,686 patients were admitted during the study period).

You may qualify if:

  • Length of ICU stay \> 48 h
  • Be at least 18 years old
  • Meet the diagnostic criteria of intensive care unit and APACH II \<35 points

You may not qualify if:

  • Patients with skin diseases and burns
  • Patients with pressury injury at admission
  • Repeat hospitalization
  • Died 24 hours after pressure injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Gaspar S, Botelho Guedes F, Vitoriano Budri AM, Ferreira C, Gaspar de Matos M. Hospital-acquired pressure ulcers prevention: What is needed for patient safety? The perceptions of nurse stakeholders. Scand J Caring Sci. 2022 Dec;36(4):978-987. doi: 10.1111/scs.12995. Epub 2021 Jun 9.

  • Stotts NA, Brown DS, Donaldson NE, Aydin C, Fridman M. Eliminating hospital-acquired pressure ulcers: within our reach. Adv Skin Wound Care. 2013 Jan;26(1):13-8. doi: 10.1097/01.ASW.0000425935.94874.41.

  • Spruce L. Strategies to Help Prevent Hospital-Acquired Pressure Injuries. AORN J. 2020 Feb;111(2):241-242. doi: 10.1002/aorn.12952. No abstract available.

  • Wood J, Brown B, Bartley A, Margarida Batista Custodio Cavaco A, Roberts AP, Santon K, Cook S. Reducing pressure ulcers across multiple care settings using a collaborative approach. BMJ Open Qual. 2019 Aug 20;8(3):e000409. doi: 10.1136/bmjoq-2018-000409. eCollection 2019.

  • Krupp AE, Monfre J. Pressure ulcers in the ICU patient: an update on prevention and treatment. Curr Infect Dis Rep. 2015 Mar;17(3):468. doi: 10.1007/s11908-015-0468-7.

  • Coyer F, Miles S, Gosley S, Fulbrook P, Sketcher-Baker K, Cook JL, Whitmore J. Pressure injury prevalence in intensive care versus non-intensive care patients: A state-wide comparison. Aust Crit Care. 2017 Sep;30(5):244-250. doi: 10.1016/j.aucc.2016.12.003. Epub 2017 Jan 4.

  • Lima Serrano M, Gonzalez Mendez MI, Carrasco Cebollero FM, Lima Rodriguez JS. Risk factors for pressure ulcer development in Intensive Care Units: A systematic review. Med Intensiva. 2017 Aug-Sep;41(6):339-346. doi: 10.1016/j.medin.2016.09.003. Epub 2016 Oct 22. English, Spanish.

  • Chaonan Y, Ji C, Huibin P, Shen L, Xiaohong L. Risk Factors for Pressure Injury in ICU Patients. Nurs Open. 2026 Feb;13(2):e70384. doi: 10.1002/nop2.70384.

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • YangChaonan Nurse-in-charge, BM

    Huzhou University

    STUDY CHAIR

Central Study Contacts

Pan Huibin licensed doctor, BM

CONTACT

JiChaohui chief physician, BM

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse-in-charge

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 4, 2022

Study Start

October 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10