Labor PainNCT05361512
Characteristics of the Tsui Test and Pressure Waveform to Confirm Epidural Catheter Placement in Parturients With BMI ≥50 kg/m2
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The prevalence of obesity has increased worldwide, and the anesthetic care of patients with obesity remains a challenge for providers despite advances. Obesity during pregnancy is a risk factor for hypertensive disorders, gestational diabetes, emergency cesarean section and higher prevalence of difficult airway. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Tsui test and epidural waveform analysis
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2022to 14 Feb 2023
- 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 18 to 55 years
- Women only
- Adult
Study population: Parturients with BMI≥50 kg/m2 requesting epidural labor analgesia or undergoing elective cesarean delivery.
Who may be able to join
- Parturients with BMI≥50 kg/m2 requesting epidural labor analgesia or undergoing elective cesarean delivery
Who cannot join
- contraindication to epidural anesthesia
- allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
- those with implanted electronic devices.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of obesity has increased worldwide, and the anesthetic care of patients with obesity remains a challenge for providers despite advances. Obesity during pregnancy is a risk factor for hypertensive disorders, gestational diabetes, emergency cesarean section and higher prevalence of difficult airway. Neuraxial techniques should always be preferred in women with obesity, particularly in those with body mass index (BMI) ≥50 kg/m2, where complications can be magnified. It is estimated an overall epidural failure rate of 4.3% in patients with obesity and an epidural failure rate of 13.7% in those with BMI ≥50 kg/m2. Hence, a confirmatory test of epidural catheter placement should prove useful in this patient population. The epidural electrical stimulation test (EEST) and the epidural waveform analysis are tests described in the literature as confirmatory methods for accuracy of placement of the epidural catheter.
The Tsui test has been well studied in obstetric patients, including required threshold electric currents and muscle contraction patterns. However, these studies have been conducted in patients receiving lumbar epidural catheters. Furthermore, they have not specifically included women with obesity class 3, particularly those with BMI≥50 kg/m2. In a recent study conducted in our department, the investigators have observed that patients with BMI≥50 kg/m2 require placement of an epidural catheter at a low-thoracic or high lumbar interspace, to allow the provision of effective surgical anesthesia for cesarean delivery, which often requires a modified incision, either transverse supra-umbilical or infra-umbilical. There are only few studies with waveform confirmation in obstetric patients showing conflicting results and certainly no studies under the circumstances described above. Finally, the Tsui test and the epidural waveform analysis have never been compared in the obstetric population.
The investigators aim to describe the characteristics of the Tsui test and of the epidural waveform analysis in parturients with BMI≥50 kg/m2 receiving epidural catheter placement at T12-L1 for both labor analgesia or anesthesia for cesarean delivery
Read the detailed description
The Tsui test has been well studied in obstetric patients, including required threshold electric currents and muscle contraction patterns. However, these studies have been conducted in patients receiving lumbar epidural catheters. Furthermore, they have not specifically included women with obesity class 3, particularly those with BMI≥50 kg/m2. In a recent study conducted in our department, the investigators have observed that patients with BMI≥50 kg/m2 require placement of an epidural catheter at a low-thoracic or high lumbar interspace, to allow the provision of effective surgical anesthesia for cesarean delivery, which often requires a modified incision, either transverse supra-umbilical or infra-umbilical. There are only few studies with waveform confirmation in obstetric patients showing conflicting results and certainly no studies under the circumstances described above. Finally, the Tsui test and the epidural waveform analysis have never been compared in the obstetric population.
- Conditions
- Labor Pain
- Being tested
- Tsui test, epidural waveform analysis
- Keywords
- epidural catheter, epidural analgesia, cesarean section, Tsui test, epidural waveform
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tsui testDevice
Also called epidural electrical stimulation test (EEST)
The stimulator is set at frequency of 1Hz with 0.2 msec pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA.
epidural waveform analysisDevice
A pressurized 500ml normal saline bag will be connected to a pressure transducer kit and the transducer will be connected to a portable monitor with the scale set at 0-40 mmHg or to optimum scale. The transducer will be levelled with the heart approximated at the patient's manubrio-sternal angle, with the patient in the sitting position. Sterile tubing will be connected to the epidural needle and attached to transducer. The tubing connection will be filled with saline to ensure proper reflection of the pressure transducer tracing. Test will be considered positive in case of pulsatile waveform is observed in synchrony with heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Patients having an epidural placed for labour analgesia or anesthesia for cesarean delivery | Patients with BMI>=50 who are having an epidural placed may take part in this study. Receives: Device: Tsui test; Device: epidural waveform analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tsui test motor response: questionnaire
Tsui test motor response will be recorded as either: left, right or bilateral. Any increase in current requirement after the test dose will be recorded.
Measured: 15 minutes
epidural waveform test (catheter) - questionnaire
A positive epidural waveform test through the catheter, defined as the presence of a pulsatile waveform observed in synchrony with heart rate: yes or no.
Measured: 15 minutes
Secondary outcomes (7)
epidural waveform test (needle) - questionnaire
A positive epidural waveform test though the needle, defined as the presence of a pulsatile waveform observed in synchrony with heart rate: yes or no
Measured: 15 minutes
Tsui test motor response (before test dose): questionnaire
Tsui test motor response will be recorded as either: left, right or bilateral.
Measured: 15 minutes
Tsui test current threshold (baseline)
Minimal electrical current required to produce a muscular contraction (mA) at baseline.
Measured: 15 minutes
Tsui test current threshold (after test dose)
Minimal electrical current required to produce a muscular contraction (mA) 5 minutes after the test dose.
Measured: 15 minutes
Laterality of the Tsui test: questionnaire
Laterality of the Tsui test, recorded as: unilateral right or left, or bilateral
Measured: 15 minutes
Location of muscle group response to Tsui test: questionnaire
Muscle group responding to the electrical stimulation: abdominal wall, thigh, lower leg, foot (left or right)
Measured: 15 minutes
Need for catheter mobilization: questionnaire
The need for catheter mobilization, including replacement (at any time after it is placed) will be documented as yes or no. The reason will also be recorded.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start21 Jun 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361512
- Sponsor's protocol ID
- 22-03
- Status last verified
- Feb 2023
- First submitted
- 29 Apr 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of the Tsui Test and Pressure Waveform to Confirm Epidural Catheter Placement in Parturients With BMI ≥50 kg/m2
- ClinicalTrials.gov ID
- NCT05361512
- Acronym / sponsor ID
- 22-03
- Conditions
- Labor Pain
- Keywords
- epidural catheter, epidural analgesia, cesarean section, Tsui test, epidural waveform
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 4 May 2022 (actual)
- 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.
The prevalence of obesity has increased worldwide, and the anesthetic care of patients with obesity remains a challenge for providers despite advances. Obesity during pregnancy is a risk factor for hypertensive disorders, gestational diabetes, emergency cesarean section and higher prevalence of difficult airway. Neuraxial techniques should always be preferred in women with obesity, particularly in those with body mass index (BMI) ≥50 kg/m2, where complications can be magnified. It is estimated an overall epidural failure rate of 4.3% in patients with obesity and an epidural failure rate of 13.7% in those with BMI ≥50 kg/m2. Hence, a confirmatory test of epidural catheter placement should prove useful in this patient population. The epidural electrical stimulation test (EEST) and the epidural waveform analysis are tests described in the literature as confirmatory methods for accuracy of placement of the epidural catheter.
The Tsui test has been well studied in obstetric patients, including required threshold electric currents and muscle contraction patterns. However, these studies have been conducted in patients receiving lumbar epidural catheters. Furthermore, they have not specifically included women with obesity class 3, particularly those with BMI≥50 kg/m2. In a recent study conducted in our department, the investigators have observed that patients with BMI≥50 kg/m2 require placement of an epidural catheter at a low-thoracic or high lumbar interspace, to allow the provision of effective surgical anesthesia for cesarean delivery, which often requires a modified incision, either transverse supra-umbilical or infra-umbilical. There are only few studies with waveform confirmation in obstetric patients showing conflicting results and certainly no studies under the circumstances described above. Finally, the Tsui test and the epidural waveform analysis have never been compared in the obstetric population.
The investigators aim to describe the characteristics of the Tsui test and of the epidural waveform analysis in parturients with BMI≥50 kg/m2 receiving epidural catheter placement at T12-L1 for both labor analgesia or anesthesia for cesarean delivery
Detailed description
The Tsui test has been well studied in obstetric patients, including required threshold electric currents and muscle contraction patterns. However, these studies have been conducted in patients receiving lumbar epidural catheters. Furthermore, they have not specifically included women with obesity class 3, particularly those with BMI≥50 kg/m2. In a recent study conducted in our department, the investigators have observed that patients with BMI≥50 kg/m2 require placement of an epidural catheter at a low-thoracic or high lumbar interspace, to allow the provision of effective surgical anesthesia for cesarean delivery, which often requires a modified incision, either transverse supra-umbilical or infra-umbilical. There are only few studies with waveform confirmation in obstetric patients showing conflicting results and certainly no studies under the circumstances described above. Finally, the Tsui test and the epidural waveform analysis have never been compared in the obstetric population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having an epidural placed for labour analgesia or anesthesia for cesarean delivery | – | Device: Tsui test, Device: epidural waveform analysisPatients with BMI>=50 who are having an epidural placed may take part in this study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Parturients with BMI≥50 kg/m2 requesting epidural labor analgesia or undergoing elective cesarean delivery.
Key inclusion criteria (1 listed)
- Parturients with BMI≥50 kg/m2 requesting epidural labor analgesia or undergoing elective cesarean delivery
Key exclusion criteria (3 listed)
- contraindication to epidural anesthesia
- allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
- those with implanted electronic devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tsui testAlso: epidural electrical stimulation test (EEST)The stimulator is set at frequency of 1Hz with 0.2 msec pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA. | Device | Patients having an epidural placed for labour analgesia or anesthesia for cesarean delivery |
| epidural waveform analysisA pressurized 500ml normal saline bag will be connected to a pressure transducer kit and the transducer will be connected to a portable monitor with the scale set at 0-40 mmHg or to optimum scale. The transducer will be levelled with the heart approximated at the patient's manubrio-sternal angle, with the patient in the sitting position. Sterile tubing will be connected to the epidural needle and attached to transducer. The tubing connection will be filled with saline to ensure proper reflection of the pressure transducer tracing. Test will be considered positive in case of pulsatile waveform is observed in synchrony with heart rate. | Device | Patients having an epidural placed for labour analgesia or anesthesia for cesarean delivery |
Primary outcome
Tsui test motor response: questionnaire
Time frame: 15 minutes
Tsui test motor response will be recorded as either: left, right or bilateral. Any increase in current requirement after the test dose will be recorded.
epidural waveform test (catheter) - questionnaire
Time frame: 15 minutes
A positive epidural waveform test through the catheter, defined as the presence of a pulsatile waveform observed in synchrony with heart rate: yes or no.
7 secondary outcomes
epidural waveform test (needle) - questionnaire
Time frame: 15 minutes
Tsui test motor response (before test dose): questionnaire
Time frame: 15 minutes
Tsui test current threshold (baseline)
Time frame: 15 minutes
Tsui test current threshold (after test dose)
Time frame: 15 minutes
Laterality of the Tsui test: questionnaire
Time frame: 15 minutes
Location of muscle group response to Tsui test: questionnaire
Time frame: 15 minutes
Need for catheter mobilization: questionnaire
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jose Carvalho, MD principal investigator
MOUNT SINAI 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 Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tsui test motor response: questionnaire (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 23 Feb 2023.