Cesarean SectionNCT04592926
Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery
A study testing Accuro SpineNav3D in people with Cesarean Section and Spinal Anesthesia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections, when performing spinal anesthesia in the lateral decubitus position on patients undergoing elective cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Spinal Anesthesia, Lumbar Ultrasound
- What is being tested?
- Accuro SpineNav3D
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 1 Dec 2021
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women
- 18 years or older
- singleton pregnancy
- at least 37 weeks gestational age
- American Society of Anesthesiologists (ASA) Classification II
- body mass index (BMI) <35 kg/m2
- plan for elective and scheduled cesarean section with spinal anesthesia
Who cannot join
- patient refusal of spinal anesthesia
- uncorrected coagulopathy
- infection at the skin site of spinal placement
- increased intracranial pressure
- untreated hemodynamic instability
- history of scoliosis or spine surgery
Show all 9Show fewer
- BMI >/=35 kg/m2
- allergy to local anesthetic
- allergy to opioids
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Naida M Cole, MD, 617-732-5000, nmcole@partners.org
About this study
Official title: The Impact of Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery: A Randomized Controlled Trial
The purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections, when performing spinal anesthesia in the lateral decubitus position on patients undergoing elective cesarean delivery.
Read the detailed description
Training in neuraxial placement most commonly occurs with patients in the sitting position, since it is easy to master. However lateral placement may be preferred in emergent situations and for patient comfort. In order to provide safe and effective anesthesia to parturients, providers must be competent with the technique in both sitting and lateral positions.
Ultrasound examination prior to spinal placement is a safe, non-invasive method of determining depth, midline, and interspinous location. Its use may decrease the number of needle insertions and needle passes in parturients in the sitting position, however little is known about the benefit of ultrasound use in the placement of lateral spinals.
The use of lumbar ultrasound with Accuro may improve success rates, safety, and the education of residents as they learn neuraxial placement in the lateral position. This will be the first study to examine the use of Accuro for lateral neuraxial placement.
The study investigators hypothesize that lumbar ultrasound with the handheld Accuro device by an experienced provider prior to spinal insertion will result in fewer needle redirections compared to palpation of landmarks when performed by anesthesia residents or fellows.
The two arms of the study are as follows:
Group 1: Control Group: sham pre-puncture ultrasound procedure with the handheld Accuro device turned off, followed by a sham marking on the participant's back using the Accuro locator marker attached to the device.
Group 2: Ultrasound Group: pre-puncture ultrasound with Accuro followed by marking placed at the L3-4 interspace in the midline using the attached Accuro locator marker.
All ultrasound exams will be performed by an unblinded physician study investigator.
All study participants will have a spinal anesthetic in lateral position performed by one of the residents or fellows participating in the study.
- Conditions
- Cesarean Section, Spinal Anesthesia, Lumbar Ultrasound
- Being tested
- Accuro SpineNav3D, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuro SpineNav3DDevice
Also called Accuro
The intervention will consist of a pre-procedural scan of the lumbar spine using the handheld image guidance device, Accuro, to determine spinal landmarks and anticipated depth of the intrathecal space.
ShamOther
The sham group will receive a pre-procedure sham scan (the handheld image guidance Accuro device will be placed on the back, but it will be turned off) followed by sham marking on the subject's back.
| Study group | Role | What they receive |
|---|---|---|
| Accuro ultrasound | Experimental | Not described Receives: Device: Accuro SpineNav3D |
| Control | Sham comparator | Not described Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Needle Redirections
Number of times the angle of the spinal introducer needle is adjusted, without exiting and re-entering the skin
Measured: through study completion, average of 3 hours
Secondary outcomes (3)
Number of Needle Passes
Number of times the spinal introducer needle exits the skin and re-enters the skin at a new location
Measured: through study completion, average of 3 hours
Procedural Time
The time from subcutaneous injection of local anesthetic prior to spinal placement until the return of cerebrospinal fluid through the spinal needle is confirmed
Measured: through study completion, average of 3 hours
Patient Satisfaction with procedure
Patient's rating of their satisfaction with the spinal procedure using a 0-10 numeric rating scale, as measured by a blinded study investigator
Measured: through study completion, average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start22 Apr 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naida Margaret Cole, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592926
- Sponsor's protocol ID
- 2020P
- Status last verified
- Apr 2021
- First submitted
- 28 Sep 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current IPD sharing plan for this data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04592926
- Acronym / sponsor ID
- 2020P
- Conditions
- Cesarean Section, Spinal Anesthesia, Lumbar Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (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 purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections, when performing spinal anesthesia in the lateral decubitus position on patients undergoing elective cesarean delivery.
Detailed description
Training in neuraxial placement most commonly occurs with patients in the sitting position, since it is easy to master. However lateral placement may be preferred in emergent situations and for patient comfort. In order to provide safe and effective anesthesia to parturients, providers must be competent with the technique in both sitting and lateral positions.
Ultrasound examination prior to spinal placement is a safe, non-invasive method of determining depth, midline, and interspinous location. Its use may decrease the number of needle insertions and needle passes in parturients in the sitting position, however little is known about the benefit of ultrasound use in the placement of lateral spinals.
The use of lumbar ultrasound with Accuro may improve success rates, safety, and the education of residents as they learn neuraxial placement in the lateral position. This will be the first study to examine the use of Accuro for lateral neuraxial placement.
The study investigators hypothesize that lumbar ultrasound with the handheld Accuro device by an experienced provider prior to spinal insertion will result in fewer needle redirections compared to palpation of landmarks when performed by anesthesia residents or fellows.
The two arms of the study are as follows:
Group 1: Control Group: sham pre-puncture ultrasound procedure with the handheld Accuro device turned off, followed by a sham marking on the participant's back using the Accuro locator marker attached to the device.
Group 2: Ultrasound Group: pre-puncture ultrasound with Accuro followed by marking placed at the L3-4 interspace in the midline using the attached Accuro locator marker.
All ultrasound exams will be performed by an unblinded physician study investigator.
All study participants will have a spinal anesthetic in lateral position performed by one of the residents or fellows participating in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Accuro ultrasound | Experimental | Device: Accuro SpineNav3D |
| Control | Sham comparator | Other: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- pregnant women
- 18 years or older
- singleton pregnancy
- at least 37 weeks gestational age
- American Society of Anesthesiologists (ASA) Classification II
Key exclusion criteria (9 listed)
- patient refusal of spinal anesthesia
- uncorrected coagulopathy
- infection at the skin site of spinal placement
- increased intracranial pressure
- untreated hemodynamic instability
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 |
|---|---|---|
| Accuro SpineNav3DAlso: AccuroThe intervention will consist of a pre-procedural scan of the lumbar spine using the handheld image guidance device, Accuro, to determine spinal landmarks and anticipated depth of the intrathecal space. | Device | Accuro ultrasound |
| ShamThe sham group will receive a pre-procedure sham scan (the handheld image guidance Accuro device will be placed on the back, but it will be turned off) followed by sham marking on the subject's back. | Other | Control |
Primary outcome
Number of Needle Redirections
Time frame: through study completion, average of 3 hours
Number of times the angle of the spinal introducer needle is adjusted, without exiting and re-entering the skin
3 secondary outcomes
Number of Needle Passes
Time frame: through study completion, average of 3 hours
Procedural Time
Time frame: through study completion, average of 3 hours
Patient Satisfaction with procedure
Time frame: through study completion, average of 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No. There is no current IPD sharing plan for this data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accuro SpineNav3D in people with Cesarean Section and Spinal Anesthesia, run by Brigham and Women's Hospital at 1 site in United States.
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 7 inclusion and 9 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 26 Apr 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Needle Redirections (time frame: through study completion, average of 3 hours). 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 26 Apr 2021.