NCT03539653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

April 23, 2018

Last Update Submit

October 5, 2018

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • gastric residual volume

    during ICU,an average of 7 days

  • nutrition indicators

    through study completion,an average of 7 days

  • the first clinical parameters of prognosis

    through study completion,an average of 7 days

  • the second clinical parameters of prognosis

    through study completion,an average of 7 days

  • the third clinical parameters of prognosis

    through study completion,an average of 7 days

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in ICU who need enteral nutrition,and the length of stay in icu\>3days

You may qualify if:

  • All patients who need enteral nutrition (through the nose) in ICU ; the length of stay in ICU \> 3 days;

You may not qualify if:

  • \<18 years old; \>90 years old; gastrointestinal surgery history； small blow nutrition； BMI\>30kg/m2; pregnancy; prone position\>4hours a day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26773077BACKGROUND

  • 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.

    PMID: 27072854BACKGROUND

  • 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.

    PMID: 28362573BACKGROUND

  • 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.

    PMID: 28811717BACKGROUND

  • 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.

    PMID: 28355374BACKGROUND

  • 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.

    PMID: 24893784BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Yan Kang, M.D.

CONTACT

18980601566kang_yan_123@163.com

Wanhong Yin, M.D.

CONTACT

13518106758doctorwhy@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 29, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

CN(1)