NCT06375148

Brief Summary

Prone ventilation is an important treatment for respiratory failure with intractable hypoxia, and the Corona Virus Disease 2019(COVID-19 ) outbreak has further elevated the status of prone ventilation. Early enteral nutrition (EN) is also recognised as an important measure to improve the prognosis of critically ill patients. However, the administration of enteral nutrition during prone position is still quite controversial. In this paper, we analysed the tolerance and safety of enteral nutrition in the prone position by reviewing studies before and after the COVID-19 outbreak. Key strategies to improve the tolerability of enteral nutrition in the prone position are also summarised and discussed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 16, 2024

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position

    Questionnaires were sent out in April, and data statistics were carried out in June

    The questionnaire method was started in April, and the data statistics were completed in June

Study Arms (4)

Zhejiang Quality Control Center

Other: Enteral nutrition

Sichuan Provincial Center for quality control of TCM critical care medicine

Other: Enteral nutrition

Severe nutrition group / nursing group of Zhejiang nutrition branch

Other: Enteral nutrition

Critical care medicine of China Research Hospital Association

Other: Enteral nutrition

Interventions

prone position ventilation

Critical care medicine of China Research Hospital AssociationSevere nutrition group / nursing group of Zhejiang nutrition branchSichuan Provincial Center for quality control of TCM critical care medicineZhejiang Quality Control Center

Eligibility Criteria

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

Medical staff working in the above ICU during the survey.

You may qualify if:

  • The intensive care unit (ICU) of the secondary grade A and above general hospitals (including traditional Chinese medicine and integrated traditional Chinese and Western medicine hospitals), including comprehensive ICU, central ICU, emergency ICU, internal medicine ICU, surgical ICU, brain ICU, and other specialized ICUs.

You may not qualify if:

  • Resident trainees, interns and other types of personnel not in the Department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhenjiang, China

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Libing Jiang, MASTER

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR
  • Chengfei Wang, MASTER

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR
  • Shanxiang Xu, MASTER

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR
  • Yongan Xu, DOCTOR

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

March 20, 2024

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations