Diagnostic and Monitoring Anesthesiology Devices Associated With Adverse IncidentsNCT02178774
Evaluation the Perfusion of Uterus and Lower Extremities During Cesarean Section With NIRS and Color Doppler
An observational study of Diagnostic and Monitoring Anesthesiology Devices Associated With Adverse Incidents, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hypotension after spinal anesthesia for cesarean section is one of the most common perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower extremities and an increase in venous capacitance. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Diagnostic and Monitoring Anesthesiology Devices Associated With Adverse Incidents
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Parturients who are going to receive an elective cesarean section in NTUH will be enrolled.
Who may be able to join
- Parturients
- elective cesarean section
- ASA class I or class II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Po-Yuan Shih, MD, 886-2-23123456 ext. 62158, b87401084@ntu.edu.tw
About this study
Official title: 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
Hypotension after spinal anesthesia for cesarean section is one of the most common perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower extremities and an increase in venous capacitance. Hypotension is a distress for both anesthesiologists and obstetricians as it endangers parturient's hemodynamics and compromises the uteroplacental blood flow. In clinical practice, there are several ways to treat hypotension after spinal anesthesia such as preloading with intravenous fluids and administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia would correlate with the perfusion of the lower extremities. To measure the perfusion of the lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared spectroscopy.
Read the 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.
- Keywords
- Near-Infrared Spectroscopy (NIRS), spinal anesthesia, cesarean section
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| parturients | tissue oxymetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygen saturation
Measured: Tissue oximeter starts recording before and every minute right after local anesthetics are injected into the intrathecal space for a total of fifteen minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic and Monitoring Anesthesiology Devices Associated With Adverse IncidentsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Yuna Shih, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178774
- Sponsor's protocol ID
- 201401059RIND
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02178774
- Acronym / sponsor ID
- 201401059RIND
- Keywords
- Near-Infrared Spectroscopy (NIRS), spinal anesthesia, cesarean section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotension after spinal anesthesia for cesarean section is one of the most common perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower extremities and an increase in venous capacitance. Hypotension is a distress for both anesthesiologists and obstetricians as it endangers parturient's hemodynamics and compromises the uteroplacental blood flow. In clinical practice, there are several ways to treat hypotension after spinal anesthesia such as preloading with intravenous fluids and administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia would correlate with the perfusion of the lower extremities. To measure the perfusion of the lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared spectroscopy.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parturients | – | –tissue oxymetry |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturients who are going to receive an elective cesarean section in NTUH will be enrolled.
Key inclusion criteria (3 listed)
- Parturients
- elective cesarean section
- ASA class I or class II
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Po-Yuna Shih, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic and Monitoring Anesthesiology Devices Associated With Adverse Incidents, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Yuan Shih, MD (886-2-23123456 ext. 62158, b87401084@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.