A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position

April 16, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We plan to carry out the following research: through multi center investigation and research, to understand the current situation of critical care workers' cognition of enteral nutrition in patients with severe prone position ventilation. 1. research purpose: to understand the current situation of cognition of critically ill medical staff on enteral nutrition in patients with severe prone position ventilation. 2. research design and methods: This study includes three parts: 1. confirmation of the research object; 2. research content and specific content of the questionnaire; 3. statistical analysis of questionnaire results. Research object: investigation unit: intensive care unit (ICU) of secondary grade A and above comprehensive hospitals (including traditional Chinese medicine and integrated traditional Chinese and Western medicine hospitals), including comprehensive ICU, central ICU, emergency ICU, medical ICU, surgical ICU, brain ICU, and other specialized ICUs. respondents: medical staff working in the above ICU during the survey. It does not include resident trainees, interns and other types of personnel who are not in the Department. Refresher trainees, if their job is ICU medical care, can also fill in the questionnaire, but it should be noted that the unit filling in is the original unit, not the refresher unit. Research content: Investigation on the current situation of medical staff's understanding of enteral nutrition in patients with severe prone position ventilation: a multicenter investigation. The questionnaire is divided into three parts (basic information, prone position ventilation information, enteral nutrition). See the questionnaire for details. The main purpose is to describe the current situation of critical care physicians' cognition of the implementation of enteral nutrition in prone position requiring mechanical ventilation. The main outcome measure was whether enteral nutrition had been started before prone position, and whether enteral nutrition would be cut off because of the need for prone position. Research methods: for the research objects that meet the inclusion criteria, the electronic questionnaire was issued in January 2023 for questionnaire survey, and the electronic questionnaire data were exported in the background in February 2023, and the questionnaire data were sorted out for statistical analysis. The main ways to issue questionnaires are as follows: 1. issue questionnaires through the quality control center of Zhejiang Province; 2. the questionnaire was distributed through the quality control center of traditional Chinese medicine critical care medicine in Sichuan Province; 3. through the severe nutrition group / nursing group of Zhejiang nutrition branch; 4. the questionnaire was distributed through the critical care medicine branch of the Chinese Research Hospital Association; 5. through the emergency world and emcrit wechat platform; 6. other ways.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zhenjiang, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Medical staff working in the above ICU during the survey.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Zhejiang Quality Control Center
Other: Enteral nutrition
prone position ventilation
Sichuan Provincial Center for quality control of TCM critical care medicine
Other: Enteral nutrition
prone position ventilation
Severe nutrition group / nursing group of Zhejiang nutrition branch
Other: Enteral nutrition
prone position ventilation
Critical care medicine of China Research Hospital Association
Other: Enteral nutrition
prone position ventilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position
Time Frame: The questionnaire method was started in April, and the data statistics were completed in June
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Libing Jiang, MASTER, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Yan2024-0052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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