Biomarkers and Bowel Sounds in Patients With Acute Gastrointestinal Injury (BABSIPWAGI)

Study on the Value of Digital Continuous Bowel Sound Monitoring in AGI of Critically Ill Patients With ICU

The incidence of gastrointestinal diseases is high in intensive care unit (intensive care unit,ICU). In critically ill patients, the intestinal tract is the "engine" of multiple organ dysfunction syndrome (Multiple organ dysfunction syndrome,MODS) and a component of multiple organ dysfunction syndrome, which is closely related to the poor prognosis of critically ill patients. In 2012, the abdominal working group of the European Association of critical Care Medicine (the European Society of Intensive Care Medicine,ESICM) put forward the concept of "acute gastrointestinal injury" (acute gastrointestinal injury,AGI), which was defined as gastrointestinal dysfunction caused by acute disease in critically ill patients. However, the grading system is complex and general, which does not reflect other gastrointestinal functions such as endocrine, immunity, barrier and so on, and lacks the support of objective laboratory results. When patients with acute gastrointestinal injury, gastrointestinal digestion and absorption, endocrine, immunity, barrier function are affected in varying degrees. The levels of indexes reflecting gastrointestinal digestion and absorption, endocrine and immunity were different among different AGI grades. The purpose of this study was to observe the characteristics of AGI bowel sounds in critically ill patients with ICU by digital continuous bowel sound monitoring, and to explore the clinical value of bowel sounds characteristics in AGI of critically ill patients combined with the changes of biomarkers of gastrointestinal injury.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Injury
• Intervention / Treatment: Other: Bowel sound

Detailed Description

In this study, digital bowel sound monitoring equipment was used to continuously monitor the bowel sound of critically ill patients with ICU. This technology added the intestinal sound characteristic database to the data processing center, analyzed and identified the intestinal sound data through the intestinal sound recognition algorithm, further analyzed the parameters such as audio frequency, spectrum and power spectrum, and observed the changes of biomarkers such as citrulline and intestinal fatty acid binding protein.

• Study Type: Observational
• Enrollment (Anticipated): 172

Contacts and Locations

• Study Contact: Name: Yuanhui Sun, Junior; Phone Number: 0086-18091991284; Email: 2370247462@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian JiaotongUniversity
      • Contact: Yuanhui Sun, Junior; Phone Number: 0086-18091991284; Email: 2370247462@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The critically ill patients treated in the Department of intensive Care of the first affiliated Hospital of Xi'an Jiaotong University were selected as the sample source.

Description

Inclusion Criteria:

• Patients ≥ 18 years old and ≤ 80 years old.
• The time of staying in ICU is expected to be more than 48 hours.
• The patient or legal guardian or legal representative signs the informed consent form.

Exclusion Criteria:

• It is estimated that the hospitalization time of ICU is less than 24 hours, and the case data are incomplete.
• Age > 80 years old; patients with chronic or primary gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, gastrointestinal ulcer), short bowel syndrome, gastrointestinal surgery (history of partial or total gastrectomy), malignant tumor.
• Pregnant or lactating women.
• Patients with severe cardiovascular disease and hemodynamic instability may have cardiorespiratory arrest in a short period of time.
• The patient himself or the agent refused to sign the informed consent form or participate in another clinical trial.
• The researchers determined that other conditions in which the patient was not suitable for selection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AGI group; Collect the characteristic data of intestinal sound, such as 24-hour average intestinal rate, duration of gastrointestinal sound, amplitude, maximum frequency, average frequency, etc., and detect citrulline, intestinal fatty acid binding protein and so on.	Other: Bowel sound; The characteristic data of bowel sounds, such as 24-hour average intestinal rate, duration of gastrointestinal sounds, amplitude, maximum frequency and average frequency, were collected to observe the differences of intestinal sounds among different AGI grades.
non-AGI group; Collect the characteristic data of intestinal sound, such as 24-hour average intestinal rate, duration of gastrointestinal sound, amplitude, maximum frequency, average frequency, etc., and detect citrulline, intestinal fatty acid binding protein and so on.	Other: Bowel sound; The characteristic data of bowel sounds, such as 24-hour average intestinal rate, duration of gastrointestinal sounds, amplitude, maximum frequency and average frequency, were collected to observe the differences of intestinal sounds among different AGI grades.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of 24-hour average intestinal sound rate	Times per minute	Days 1, 2, 3, 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of citrulline level	μmol/L	Days 1, 2, 3, 7
Changes of intestinal fatty acid binding protein level	ng/L	Days 1, 2, 3, 7
Changes of motilin level	ng/L	Days 1, 2, 3, 7
Changes of gastrin level	ng/L	Days 1, 2, 3, 7

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Qindong Shi, Chief, Director of Intensive Care Unit

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2021
• Primary Completion (ANTICIPATED): September 25, 2022
• Study Completion (ANTICIPATED): September 25, 2022

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (ACTUAL): February 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; Critically ill patients; Continuous bowel sound detection
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: XJTU1AF2021LSK-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No