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

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.

Study Overview

• Status: Unknown
• Conditions: Blood Circulation Disorder

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 Type: Observational
• Enrollment (Anticipated): 201

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Ting Zhu, PhD; Phone Number: +86-18101878907; Email: zhuting@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with limb fractures diagnosed by X-ray film

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Limb Blood circulation disorder	Number of participants with circulatory disorders (using mannitol treatment) after limb fracture	Within 1 year after mannitol treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	The adverse events include acute ischemic necrosis, osteofascial compartment syndrome and disability.	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.	Within 1 year after mannitol treatment

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Ting Zhu, PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Children; limb Fracture; limb blood circulation; early-warning model
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: XH-18-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No