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Randomized controlled trial on X-ray general artificial intelligence for assisting diagnosis of bone and important organ diseases

Randomized controlled trial on X-ray general artificial intelligence for assisting diagnosis of bone and important organ diseases

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097130
Enrollment
Unknown
Registered
2025-02-13
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures in all parts of the body, pneumonia, and intestinal obstruction

Interventions

Gold Standard:The gold standard for diagnosing a fracture is having any one of the following: ? a history of trauma, severe pain in the affected area, and limited mobility
? Any one of limb deformities, abnormal activity, or bone fricative sounds
? CT images show any of the following signs: cortical fracture, bone transparency line shadow, cortical compression distortion, free bone slice or fragmented bone block
The gold standard for diagnosing pneumonia is to have any one of the following conditions (1), (2), (3), (4), accompanied by condition (5): (1) recent onset or worsening of pre-existing respiratory sy
(2) Fever
? Signs of lung consolidation and/or wet rales
? Peripheral blood white matter count>10 × 10 ^ 9/L or<4 × 10 ^ 9/L, with or without left nuclear shift
? CT shows new patchy or patchy infiltrative shadows or interstitial changes with or without pleural effusion
The gold standard for diagnosing intestinal obstruction is: having any one of the following conditions: ? abdominal pain, bloating, nausea, vomiting, anal weakness, cessation of bowel movements, and a
? Physical examination suggests the presence of varying degrees of bloating, intestinal peristalsis waves, and intestinal types
Soft abdominal wall with or without slight tenderness
? High pitched metallic intestinal sounds or sounds similar to those produced when air blows over water during abdominal percussion
? CT shows dilation of the intestinal tract, thickening of the intestinal wall, narrowing of the intestinal lumen, and inflation of the intestinal tract. The criteria for a negative diagnosis of the a

Sponsors

Guizhou Aerospace Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age: 18-75 years old. 2.This study included patients suspected of having fractures, pneumonia, or intestinal obstruction who required X-ray imaging examination, The inclusion criteria for fracture patients are those who have any one of the following two conditions: 1) a history of trauma, severe pain in the affected area, and limited mobility; 2) Any of limb deformities, abnormal activity, or bone fricatives; The inclusion criteria for pneumonia patients refer to the diagnostic criteria for community-acquired pneumonia, and any one of the following four conditions can be included: 1) newly appeared or aggravated respiratory symptoms; 2) Fever; 3) Signs of lung consolidation and/or wet rales; 4) Peripheral blood white matter count>10 × 10 ^ 9/L or<4 × 10 ^ 9/L, with or without left nuclear shift; The inclusion criteria for patients with intestinal obstruction are any one of the following three conditions: 1) abdominal pain, bloating, nausea, vomiting, anal weakness, cessation of bowel movements, and a history of abdominal surgery or inflammation; 2) Physical examination suggests the presence of varying degrees of bloating, intestinal peristalsis waves, and intestinal types; Soft abdominal wall with or without slight tenderness; 3) High pitched metallic intestinal sounds or sounds similar to those produced when air blows over water during abdominal percussion; 3.Sign the informed consent form, understand and agree to comply with the requirements and experimental procedures of the study.

Exclusion criteria

Exclusion criteria: 1. Patients with unstable vital signs. 2. Unconscious patients. 3. Suspect having both or all of fractures, pneumonia, and intestinal obstruction at the same time.

Design outcomes

Primary

MeasureTime frame
sensitivity;

Secondary

MeasureTime frame
specificity;accuracy;area under the curve, AUC;mortality rate in 30 days;ICU rate;sepsis rate;shock rate;severe pneumonia rate;usage rate of ventilator or tracheal intubation;

Countries

China

Contacts

Public ContactJiong Mei

Guizhou Aerospace Hospital

meijiong@sjtu.edu.cn+86 139 0187 0631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026