- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539653
The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
October 5, 2018 updated by: Kang Yan
The purpose of this study is to investigate the effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Kang, M.D.
- Phone Number: 18980601566
- Email: kang_yan_123@163.com
Study Contact Backup
- Name: Wanhong Yin, M.D.
- Phone Number: 13518106758
- Email: doctorwhy@126.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital
-
Contact:
- Yan Kang, M.D
- Phone Number: 18980601566
- Email: kang_yan_123@163.com
-
-
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
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients in ICU who need enteral nutrition,and the length of stay in icu>3days
Description
Inclusion Criteria:
All patients who need enteral nutrition (through the nose) in ICU ; the length of stay in ICU > 3 days;
Exclusion Criteria:
<18 years old; >90 years old; gastrointestinal surgery history; small blow nutrition; BMI>30kg/m2; pregnancy; prone position>4hours a day
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of tube feeding intolerance during ICU
Time Frame: during ICU,an average of 7 days
|
incidence of tube feeding intolerance during ICU,such as vomit,diarrhea,Bloating.
|
during ICU,an average of 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gastric residual volume
Time Frame: during ICU,an average of 7 days
|
gastric residual volume during ICU
|
during ICU,an average of 7 days
|
nutrition indicators
Time Frame: through study completion,an average of 7 days
|
nutrition indicators during ICU,such as prealbumin
|
through study completion,an average of 7 days
|
the first clinical parameters of prognosis
Time Frame: through study completion,an average of 7 days
|
incidence of regurgitation during enteral nutrition
|
through study completion,an average of 7 days
|
the second clinical parameters of prognosis
Time Frame: through study completion,an average of 7 days
|
ventilator-associated pneumonia
|
through study completion,an average of 7 days
|
the third clinical parameters of prognosis
Time Frame: through study completion,an average of 7 days
|
length of mechanic ventilation during ICU
|
through study completion,an average of 7 days
|
the forth clinical parameters of prognosis
Time Frame: through study completion,an average of 7 days
|
length of stay in ICU
|
through study completion,an average of 7 days
|
the fifth clinical parameters of prognosis
Time Frame: through study completion,an average of 15 days
|
hospital mortality
|
through study completion,an average of 15 days
|
the sixth clinical parameters of prognosis
Time Frame: through study completion,an average of 7 days
|
hospitalization costs during ICU
|
through study completion,an average of 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Yuan Xu, M.D., Beijing Tsinghua Changgeng Hospital
- Study Chair: Wei He, Beijing Tongren Hospital
- Study Chair: Yi Yang, Zhongda Hospital
- Study Chair: Bin Ouyang, The first affiliation hospital,Sun Yat-sen university
- Study Chair: Ran Zhu, First Hospital of China Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.
- Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
- Bisinotto FM, Pansani PL, Silveira LA, Naves AA, Peixoto AC, Lima HM, Martins LB. Qualitative and quantitative ultrasound assessment of gastric content. Rev Assoc Med Bras (1992). 2017 Feb;63(2):134-141. doi: 10.1590/1806-9282.63.02.134.
- Warren M, McCarthy MS, Roberts PR. Practical Application of the Revised Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: A Case Study Approach. Nutr Clin Pract. 2016 Jun;31(3):334-41. doi: 10.1177/0884533616640451. Epub 2016 Apr 12.
- Sharma V, Gudivada D, Gueret R, Bailitz J. Ultrasound-Assessed Gastric Antral Area Correlates With Aspirated Tube Feed Volume in Enterally Fed Critically Ill Patients. Nutr Clin Pract. 2017 Apr;32(2):206-211. doi: 10.1177/0884533616681530. Epub 2016 Dec 16.
- Liu Y, Gao YK, Yao L, Li L. Modified B-ultrasound method for measurement of antral section only to assess gastric function and guide enteral nutrition in critically ill patients. World J Gastroenterol. 2017 Jul 28;23(28):5229-5236. doi: 10.3748/wjg.v23.i28.5229.
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)
May 1, 2018
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
April 23, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (Actual)
May 29, 2018
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GUS
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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