Critically IllNCT03539653
The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
An observational study of Critically Ill, run by Kang Yan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critically Ill
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Jul 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in ICU who need enteral nutrition,and the length of stay in icu>3days
Who may be able to join
- All patients who need enteral nutrition (through the nose) in ICU ; the length of stay in ICU > 3 days;
Who cannot join
- <18 years old; >90 years old; gastrointestinal surgery history； small blow nutrition； BMI>30kg/m2; pregnancy; prone position>4hours a day
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Yan Kang, M.D, 18980601566, kang_yan_123@163.com
About this study
The purpose of this study is to investigate the effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
- Conditions
- Critically Ill
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of tube feeding intolerance during ICU
incidence of tube feeding intolerance during ICU，such as vomit，diarrhea，Bloating.
Measured: during ICU,an average of 7 days
Secondary outcomes (8)
gastric residual volume
gastric residual volume during ICU
Measured: during ICU,an average of 7 days
nutrition indicators
nutrition indicators during ICU,such as prealbumin
Measured: through study completion,an average of 7 days
the first clinical parameters of prognosis
incidence of regurgitation during enteral nutrition
Measured: through study completion,an average of 7 days
the second clinical parameters of prognosis
ventilator-associated pneumonia
Measured: through study completion,an average of 7 days
the third clinical parameters of prognosis
length of mechanic ventilation during ICU
Measured: through study completion,an average of 7 days
the forth clinical parameters of prognosis
length of stay in ICU
Measured: through study completion,an average of 7 days
the fifth clinical parameters of prognosis
hospital mortality
Measured: through study completion,an average of 15 days
the sixth clinical parameters of prognosis
hospitalization costs during ICU
Measured: through study completion,an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 May 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Yan
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Chang Gung Hospital, Zhongda Hospital, First Hospital of China Medical University, Beijing Tongren Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor-investigator, Kang Yan, West China Hospital
- Investigators
- Yuan Xu, M.D., Study chair, Beijing Tsinghua Changgeng HospitalWei He, Study chair, Beijing Tongren HospitalYi Yang, Study chair, Zhongda HospitalBin Ouyang, Study chair, The first affiliation hospital,Sun Yat-sen universityRan Zhu, Study chair, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539653
- Sponsor's protocol ID
- GUS
- Status last verified
- Oct 2018
- First submitted
- 23 Apr 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26773077Warren 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.
PubMed 27072854Sharma 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.
PubMed 28362573Liu 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.
PubMed 28811717Bisinotto 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.
PubMed 28355374Van 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.
PubMed 24893784
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gastric Antrum Ultrasonography on Early Stage of Enteral Nutrition in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT03539653
- Acronym / sponsor ID
- GUS
- Conditions
- Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Kang YanUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Chang Gung Hospital, Zhongda Hospital, First Hospital of China Medical University, Beijing Tongren Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 29 May 2018 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in ICU who need enteral nutrition,and the length of stay in icu>3days
Key inclusion criteria (1 listed)
- All patients who need enteral nutrition (through the nose) in ICU ; the length of stay in ICU > 3 days;
Key exclusion criteria (1 listed)
- <18 years old; >90 years old; gastrointestinal surgery history； small blow nutrition； BMI>30kg/m2; pregnancy; prone position>4hours a day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
gastric residual volume
Time frame: during ICU,an average of 7 days
nutrition indicators
Time frame: through study completion,an average of 7 days
the first clinical parameters of prognosis
Time frame: through study completion,an average of 7 days
the second clinical parameters of prognosis
Time frame: through study completion,an average of 7 days
the third clinical parameters of prognosis
Time frame: through study completion,an average of 7 days
the forth clinical parameters of prognosis
Time frame: through study completion,an average of 7 days
the fifth clinical parameters of prognosis
Time frame: through study completion,an average of 15 days
the sixth clinical parameters of prognosis
Time frame: through study completion,an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Background: PubMed 26773077McClave 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.
- Background: PubMed 27072854Warren 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.
- Background: PubMed 28362573Sharma 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.
- Background: PubMed 28811717Liu 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.
- Background: PubMed 28355374Bisinotto 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.
- Background: PubMed 24893784Van 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.
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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.
Yuan Xu, M.D. study chair
Beijing Tsinghua Changgeng Hospital
Wei He study chair
Beijing Tongren Hospital
Yi Yang study chair
Zhongda Hospital
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 Critically Ill, run by Kang Yan 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 9 Oct 2018. 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?
Contact Yan Kang, M.D. (18980601566, kang_yan_123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of tube feeding intolerance during ICU (time frame: during ICU,an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539653, which also lists 6 linked publications.
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 9 Oct 2018.