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.
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
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.
- Conditions
- Enteral Nutrition, Prone Position
- 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 group | Role | What they receive |
|---|---|---|
| Zhejiang Quality Control Center | Not described Receives: Other: Enteral nutrition | |
| Sichuan Provincial Center for quality control of TCM critical care medicine | Not described Receives: Other: Enteral nutrition | |
| Severe nutrition group / nursing group of Zhejiang nutrition branch | Not described Receives: Other: Enteral nutrition | |
| Critical care medicine of China Research Hospital Association | Not described Receives: Other: Enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted19 Apr 2024
- Study start20 Mar 2024
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Libing Jiang, MASTER, Study director, Second Affiliated Hospital, Zhejiang University, School of MedicineChengfei Wang, MASTER, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineShanxiang Xu, MASTER, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineYongan Xu, DOCTOR, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position
- ClinicalTrials.gov ID
- NCT06375148
- Acronym / sponsor ID
- Yan2024-0052
- Conditions
- Enteral Nutrition, Prone Position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Medical staff working in the above ICU during the survey.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Resident trainees, interns and other types of personnel not in the Department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral nutritionprone position ventilation | Other | Critical care medicine of China Research Hospital Association, Severe nutrition group / nursing group of Zhejiang nutrition branch, Sichuan Provincial Center for quality control of TCM critical care medicine, Zhejiang Quality Control Center |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Libing Jiang, MASTER study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
Chengfei Wang, MASTER principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Shanxiang Xu, MASTER principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
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.