Novel Test Method for Non-Obstructive Mesenteric Ischemia (NOMI)

JRCT ID: jRCTs032230527

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients admitted to the esophago-gastrointestinal surgical ward or ICU (regardless of disease)
• Date of first enrollment: 11/01/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Perform examination for NOMI using a novel technique with a diagnostic ultrasound system.

Outcome(s)

• Primary Outcome: Tolerability of new testing methods
• Secondary Outcome: Detection rate in each organ

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with suspected NOMI: Patients suspected of developing NOMI
1) Patients who have given consent to participate in this study, either by themselves or by a surrogate
2) Patients who are 20 years of age or older
3) Patients who have consulted with the Department of Esophagology and Gastroenterology, Chiba University Hospital
4) Patients with abdominal findings such as abdominal pain, abdominal distention, and any of the following
(1) Worsening or new onset of circulatory failure
(2) Prolonged elevation of Lactate in blood

Non-NOMI patients: Control patients without organ failure
1) Patients who are 20 years old or older.
2) Patients who were admitted to the Department of Esophago-Gastrointestinal Surgery, Chiba University Hospital by walking in for scheduled surgery.
3) Patients who have obtained consent for participation in this study from themselves or their significant others.

Exclude criteria

<Exclusion criteria common to both NOMI and non-NOMI patients>
1) Patients who are unable to perform ultrasound examinations due to inability to carry the equipment to the bedside.
2) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding
3) Patients who are deemed by the physician to be inappropriate for the safe conduct of this study

<Exclusion criteria for non-NOMI patients>
1) Patients with abdominal symptoms on admission
2) Patients who cannot walk independently

Related Information

• Primary Sponsor: Ohira Gaku
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital),Future Medicine Education and Research Organization at Chiba University