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

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ClinicalTrials.gov Identifier: NCT02280512
Recruitment Status : Unknown
Verified May 2015 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment
Femoral Fractures Tibial Fractures Device: elderly with fractures

Detailed Description:

Aging is associated with progressive loss of functional reserve in all organ systems. For most people, physiologic compensation for age-related changes is adequate. However, it is easy to decompensate under stressful circumstances, such as surgery and illness. Under the specific physiologic phenomenon, geriatric anesthesia is acquired for more intensive monitoring. 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. For the elderlies with fracture are more vulnerable to have complications, poor prognosis and decompensated organ functions.

In our daily practice, the surgeries for fracture in lower extremities can performed under either general anesthesia or regional anesthesia, such as spinal anesthesia epidural anesthesia, and nerve block. The anesthetic method is determined under each patient's condition. EKG, arterial catheter, pulse oximeter are usually basic for intra-operative monitoring. However, these tools are unable to inform us the real-time cardiac output and the exact status of tissue perfusion. Nowadays, there are many non-invasive instruments able to estimate more detailed hemodynamic parameters, which are very crucial during anesthesia.1 But these instruments are not widely used in our daily practices. We need more researches to support the beneficial roles of these non-invasive monitors to high-risk patients during surgery.

Due to the hemodynamic feature in elderlies, we will use conventional measurements as EKG, arterial blood pressure and pulse oximeter. To measure the perfusion of the lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared spectroscopy (NIRS).2,3 NIRS was used as the cerebral oximetry to measure the tissue perfusion of the cerebral cortex. It uses reflectance oximetry to measure the oxygen saturation of the tissue underneath the sensor.1 Recently, NIRS has been proved not only to continuously monitor tissue oxygenation saturation (StO2) continuously, but also to predict the patient's poor prognosis.3,4 To measure the cardiac output intra-operatively, we will use the non-invasive cardiac output monitor (NICOM®, Cheetah). Bioreactance technique allows the measurement of hemodynamic changes via four electrodes placed on the thorax. The electrical current crossing the thorax makes "signal phase shift", which is related to changes in the volume of the thoracic aorta. Thus, the volume change in the thoracic aorta is able to estimate stroke volume.1,5 Postoperative prognosis is adjusted with the recovery of ambulation, the duration of ICU stay, the morbidity and mortality, and the questionnaire (SF-36) about quality of life.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Monitoring With Noninvasive Near-infrared Spectroscopy and Noninvasive Cardiac Output Measurement, and Postoperative Outcome in Elderly Patients With Fractures of Lower Extremities
Study Start Date : December 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
elderly with fractures
patients more than 65 years old accepting surgeries for lower extremities fracture
Device: elderly with fractures
hemodynamic monitoring with NICOM and tissue perfusion monitoring with NIRS




Primary Outcome Measures :
  1. Psychometric status in 3 months after the surgery [ Time Frame: 3 months ]
    Evaluation via questionnaire, SF-36


Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 2 Days ]
    If the patient was admitted to intensive care units(ICU) after the operation, the duration of staying in ICU is recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient older than 65 years old with fractures of lower limbs
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280512


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Po-Yuan Shih National Taiwan University
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02280512    
Other Study ID Numbers: 201407114RIND
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by National Taiwan University Hospital:
noninvasive cardiac output measurement(NICOM)
Leg fractures
Near-Infrared Spectroscopy (NIRS)
Intensive care unit(ICU)
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Tibial Fractures
Wounds and Injuries
Leg Injuries