The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.

Critically Ill Clinical Trial

Official title:

The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03539653
• Other study ID #: GUS
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2018
• Source: West China Hospital
• Contact: Yan Kang, M.D.
• Phone: 18980601566
• Email: kang_yan_123[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (6)

Lead Sponsor	Collaborator
Kang Yan	Beijing Tongren Hospital, Beijing Tsinghua Chang Gung Hospital, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of tube feeding intolerance during ICU	incidence of tube feeding intolerance during ICU,such as vomit,diarrhea,Bloating.	during ICU,an average of 7 days
Secondary	gastric residual volume	gastric residual volume during ICU	during ICU,an average of 7 days
Secondary	nutrition indicators	nutrition indicators during ICU,such as prealbumin	through study completion,an average of 7 days
Secondary	the first clinical parameters of prognosis	incidence of regurgitation during enteral nutrition	through study completion,an average of 7 days
Secondary	the second clinical parameters of prognosis	ventilator-associated pneumonia	through study completion,an average of 7 days
Secondary	the third clinical parameters of prognosis	length of mechanic ventilation during ICU	through study completion,an average of 7 days
Secondary	the forth clinical parameters of prognosis	length of stay in ICU	through study completion,an average of 7 days
Secondary	the fifth clinical parameters of prognosis	hospital mortality	through study completion,an average of 15 days
Secondary	the sixth clinical parameters of prognosis	hospitalization costs during ICU	through study completion,an average of 7 days