Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

• Conditions: Blood Circulation Disorder

• Registration Number: NCT03700216
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. The investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.

Detailed Description

The investigator will retrospect the data of operative patients with limb fracture in Pediatric Orthopedics Unit of Shanghai Xinhua Hospital in 2016 to collect the basic information about this kind of patient, including age, gender, kind of fracture, temperature and color of skin, swell, artery pulse, laboratory test indicators, method of fixation, and the usage of mannitol. Then, combining the professionals' suggestions, the investigator will use multi-factor regression to identify the independent risk factors of blood circulation disorder. According to the independent risk factors, the early-warning model of blood circulation disorder will be built, and the rating scale as well. Finally, the critical value of blood circulation disorder after limb fracture will be set by receiver operating characteristic curve.

Study Timeline

• Study First Submitted: 2018-09-26
• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-19
• Primary Completion: 2019-12-31
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Age from 0 to 14 years;
• Children with limb fractures diagnosed by X-ray film;
• The surgical method is open reduction and wire-pin fixation or steel plate internal fixation;
• Children with postoperative plaster fixation;
• Children whose guardian signed informed written consent.

Exclusion Criteria

• Children with nerve damage which have caused dysfunction such as sensory and motor;
• Children with fracture in other parts or organic diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with Limb Blood circulation disorder	Within 1 year after mannitol treatment	Number of participants with circulatory disorders (using mannitol treatment) after limb fracture

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Within 1 year after mannitol treatment	The adverse events include acute ischemic necrosis, osteofascial compartment syndrome and disability.
Blood oxygen saturation at the end of extremities	Within 1 year after mannitol treatment	Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood, which can reflect the status of blood circulation. Blood oxygen saturation can be get by using percutaneous oxygen saturation monitor.

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China