Clinical trial NCT03539653: The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
Official title: The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tsinghua Chang Gung Hospital
name: Zhongda Hospital
name: First Hospital of China Medical University
name: Beijing Tongren Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2018-05-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in ICU who need enteral nutrition,and the length of stay in icu\>3days

Brief summary: The purpose of this study is to investigate the effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of tube feeding intolerance during ICU
timeFrame: during ICU,an average of 7 days
Secondary outcomes:
measure: gastric residual volume
timeFrame: during ICU,an average of 7 days
measure: nutrition indicators
timeFrame: through study completion,an average of 7 days
measure: the first clinical parameters of prognosis
timeFrame: through study completion,an average of 7 days
measure: the second clinical parameters of prognosis
timeFrame: through study completion,an average of 7 days
measure: the third clinical parameters of prognosis
timeFrame: through study completion,an average of 7 days
measure: the forth clinical parameters of prognosis
timeFrame: through study completion,an average of 7 days
measure: the fifth clinical parameters of prognosis
timeFrame: through study completion,an average of 15 days
measure: the sixth clinical parameters of prognosis
timeFrame: through study completion,an average of 7 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Yuan Xu, M.D.
role: STUDY_CHAIR
affiliation: Beijing Tongren Hospital
name: Wei He
role: STUDY_CHAIR
affiliation: Zhongda Hospital
name: Yi Yang
role: STUDY_CHAIR
affiliation: The first affiliation hospital,Sun Yat-sen university
name: Bin Ouyang
role: STUDY_CHAIR
affiliation: First Hospital of China Medical University
name: Ran Zhu
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.