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Enteral NutritionNCT06375148

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

An observational study of Enteral Nutrition and Prone Position, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Enteral Nutrition, Prone Position
What is being tested?
Enteral nutrition
How many people
200 participants
Where
1 siteChina
Study dates
20 Mar 2024to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Medical staff working in the above ICU during the survey.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Zhenjiang

Other trials in China

About this study

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.

Read the 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.

Being tested
Enteral nutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enteral nutritionOther

    prone position ventilation

Study groups in NCT06375148
Study groupRoleWhat they receive
Zhejiang Quality Control CenterNot described
Receives: Other: Enteral nutrition
Sichuan Provincial Center for quality control of TCM critical care medicineNot described
Receives: Other: Enteral nutrition
Severe nutrition group / nursing group of Zhejiang nutrition branchNot described
Receives: Other: Enteral nutrition
Critical care medicine of China Research Hospital AssociationNot described
Receives: Other: Enteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start20 Mar 2024
  3. Primary completion30 May 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06375148
Sponsor's protocol ID
Yan2024-0052
Status last verified
Apr 2024
First submitted
16 Apr 2024
Last updated
19 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Enteral Nutrition and Prone Position, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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