a Ultrasonographic Measurement of Intra-abdominal Pressure

NCT06390605 | Not Yet Recruiting

• 1 other identifier: ZWQ21886-2024-1
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Intra-abdominal pressure (IAP) refers to the stable pressure in a closed cavity. Its magnitude is determined by the compliance of the abdominal wall and the pressure of the abdominal cavity contents, and it increases with inhalation and decreases with exhalation. Due to fluid retention, organ failure, use of ventilators, and other reasons, critically ill patients have higher intra-abdominal pressure, ranging from 5-7mmHg. However, the expansion capacity of the peritoneal cavity is limited. As the internal pressure rises, when the intra-abdominal pressure rises above 12 mmHg, intra-abdominal hypertension (IAH) occurs. Elevated IAP has harmful physiological effects on almost all organ systems, including the central nervous system, cardiovascular, respiratory, kidney, gastrointestinal, and liver systems. When IAP continues to rise and is accompanied by new or progressive organ failure, it develops into abdominal compartment syndrome (ACS), which is the end-stage manifestation of severe IAH. Currently, there are various methods for measuring intra-abdominal pressure, including direct intraperitoneal measurement, transbladder measurement, gastric measurement, superior and inferior vena cava measurement, rectal measurement, and noninvasive measurement. However, the most commonly used clinical method is indirect transbladder measurement. This technique is clinically feasible and accurate, making it the internationally recognized "gold standard" for intra-abdominal pressure monitoring. Nevertheless, it has been reported that the accuracy and reproducibility of intra-bladder pressure measurements can be influenced by many factors, resulting in a large coefficient of variation in intra-abdominal pressure measurements obtained by this method. Additionally, the indirect transbladder measurement technique is cumbersome, discontinuous, and carries a potential risk of infection. Therefore, the development of noninvasive, safe, and reliable IAP monitoring techniques or methods has garnered widespread attention from scholars both domestically and internationally. This study measures IAP using a combination of ultrasound and external pressure application. By comparing it with the gold standard, intra-bladder pressure measurement, we observe the accuracy and reliability of this measurement method. The aim is to provide a noninvasive, fast, accurate, and reliable method for measuring intra-abdominal pressure in critically ill patients.

Conditions

Critical Care

Outcome Measures

Primary Outcomes (1)

• Pearson correlation coefficient

  Pearson correlation coefficient between golden standard and ultrasonographic method

  From May 2024 to April 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients admitted to a tertiary hospitals in Shanghai, China from May 2024 to April 2025

You may qualify if:

• Patients with indwelling catheters who can undergo intra-bladder pressure measurement.
• Patients suspected of having elevated intra-abdominal pressure.
• Patients who have agreed to participate in this study and signed a written informed consent form, either by themselves or through their immediate family members.

You may not qualify if:

• Patients with wounds in the middle of the abdominal wall, making it impossible to perform abdominal wall pressure measurements.
• Patients with pathological changes in the abdominal wall, such as congenital malformations, injuries, hematomas within the rectus sheath, infections, tumors, hernias, etc.
• Patients whose water column does not show respiratory phase changes during intra-bladder pressure measurement.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

• weiqing zhang, Ph.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

weiqing zhang, Ph.D.

CONTACT

86 18521525300; weiq.zh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)