Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. maj 2015 opdateret af: National Taiwan University Hospital

Intraoperative Monitoring With Noninvasive Near-infrared Spectroscopy and Noninvasive Cardiac Output Measurement, and Postoperative Outcome in Elderly Patients With Fractures of Lower Extremities

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.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patient older than 65 years old with fractures of lower limbs

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
elderly with fractures
patients more than 65 years old accepting surgeries for lower extremities fracture
hemodynamic monitoring with NICOM and tissue perfusion monitoring with NIRS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychometric status in 3 months after the surgery
Tidsramme: 3 months
Evaluation via questionnaire, SF-36
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU stay
Tidsramme: 2 Days
If the patient was admitted to intensive care units(ICU) after the operation, the duration of staying in ICU is recorded.
2 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Po-Yuan Shih, National Taiwan University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Forventet)

1. oktober 2015

Studieafslutning (Forventet)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

27. oktober 2014

Først indsendt, der opfyldte QC-kriterier

29. oktober 2014

Først opslået (Skøn)

31. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lårbensbrud

Kliniske forsøg med elderly with fractures

Abonner