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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine201 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

201

Conditions

Blood Circulation Disorder

Eligibility

Sex: ALLMax age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Number of participants with Limb Blood circulation disorder

Number of participants with circulatory disorders (using mannitol treatment) after limb fracture

Time frame: Within 1 year after mannitol treatment

Secondary Outcomes

Number of adverse events

The adverse events include acute ischemic necrosis, osteofascial compartment syndrome and disability.

Time frame: Within 1 year after mannitol treatment

Blood oxygen saturation at the end of extremities

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.

Time frame: Within 1 year after mannitol treatment

Central Contacts

Ting Zhu, PhD

CONTACT

+86-18101878907 zhuting@xinhuamed.com.cn

Data from ClinicalTrials.gov

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