Intra-op Monitoring With NIRS and NICOM, and Surgical Outcome in Elderly Patients With Fractures of Lower Limbs

NCT02280512 | Unknown

• 1 other identifier: 201407114RIND
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, about 75.92% of the elderlies above 65 years old suffered from chronic diseases or major diseases, especially in circulatory system. Thus, dramatic hemodynamic change is often observed in surgeries in this population. Due to osteoporosis and high-prevalence morbidities, trauma with fracture is quite common. These elderlies are more vulnerable to have complications, poor prognosis and decompensated organ functions. The investigators would like to observe the perfusion of different tissue intra-operatively, and to find the correlation with surgical outcome. There are many non-invasive hemodynamic monitors nowadays. In our study, the investigators will use noninvasive cardiac output measurement(NICOM), and non-invasive transcutaneous near infrared spectroscopy(NIRS) to observe hemodynamic change and tissue perfusion. After the surgery, the duration in ICU will be recorded. A questionnaire, SF-36, will be mailed to the patients 2 months after the surgery to measure the psychometric status.

Conditions

Femoral Fractures; Tibial Fractures

Keywords

noninvasive cardiac output measurement(NICOM); Leg fractures; Near-Infrared Spectroscopy (NIRS); Intensive care unit(ICU)

Outcome Measures

Primary Outcomes (1)

• Psychometric status in 3 months after the surgery

  Evaluation via questionnaire, SF-36

  3 months

Secondary Outcomes (1)

• ICU stay

  2 Days

Study Arms (1)

elderly with fractures

patients more than 65 years old accepting surgeries for lower extremities fracture

Device: elderly with fractures

Interventions

elderly with fractures DEVICE

hemodynamic monitoring with NICOM and tissue perfusion monitoring with NIRS

elderly with fractures

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient older than 65 years old with fractures of lower limbs

You may qualify if:

• Patients more than 65 years old accepting surgeries for lower extremities fracture

You may not qualify if:

• Skin lesions over the sites where NIRS patches and NICOM electrodes are about to be attached.
• Patients with history of being allergic to NIRS patches or NICOM electrodes.
• Patients with pleural effusion or pericardial effusion.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Po-Yuan Shih

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 31, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

TW (1)