- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02178774
Evaluation the Perfusion of Uterus and Lower Extremities During Cesarean Section With NIRS and Color Doppler
Using Non-invasive Near-infrared Spectroscopy and Color Doppler to Evaluate the Relationship Between the Perfusion of Uterus and Gastrocnemius Muscles of the Parturients Receiving Cesarean Section
Study Overview
Status
Detailed Description
This is a prospective observational study. Parturients who are going to receive an elective cesarean section will be enrolled. Before entering the operating rooms, the parturient enrolled receives the Doppler studies. The external iliac artery is identified and color Doppler is activated to locate the uterine artery crossed the external iliac artery. The probe is stabilized to obtain the maximum flow velocity waveform.The pulsatility index of these three waveforms is calculated and recorded as the baseline. Three minutes after the anesthetics are injected, the same procedures of color Doppler are performed again, and the PI after the spinal anesthesia is recorded.
Tissue (cerebral) oximeter (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA) is used for the NIRS technique. Two adhesive sensor patches are attached to the parturient. One sensor patch is applied over the the biceps brachii of the upper limb while the other adhere to the medial side of the gastrocnemius muscle. After the oximeter shows a stable reading, the baseline data are recorded. The parturient then receive spinal anesthesia in the right lateral decubitus position. The intrathecal injection consists of 0.5% hyperbaric bupivacaine. NIBP is monitored at 2.5 minutes interval for 30 minutes. Tissue oximeter starts recording every minute right after local anesthetics are injected into the intrathecal space for a total of fifteen minutes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Po-Yuan Shih, MD
- Phone Number: 62158 886-2-23123456
- Email: b87401084@ntu.edu.tw
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Contact:
- Po-Yuan Shih, MD
- Phone Number: 62158 886-2-23123456
- Email: b87401084@ntu.edu.tw
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Parturients
- elective cesarean section
- ASA class I or class II
Exclusion Criteria:
- Emergent cesarean section
- Skin lesions over the site of local anesthetic injection
- Skin lesions over the sites where NIRS patches are about to be attached
- Patients with history of being allergic to NIRS patches
- Patients with coagulopathy or other contraindications for spinal anesthesia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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parturients
tissue oxymetry
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tissue oxygen saturation
Time Frame: Tissue oximeter starts recording before and every minute right after local anesthetics are injected into the intrathecal space for a total of fifteen minutes.
|
Tissue oximeter starts recording before and every minute right after local anesthetics are injected into the intrathecal space for a total of fifteen minutes.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Po-Yuna Shih, MD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 201401059RIND
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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