PregnancyNCT01444638
Evaluation of Ultrasound (US) Assistance for Anesthesia Trainees for Caesarean Section Spinal Placement
A study testing Ultrasound examination in people with Pregnancy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ultrasound examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Sep 2012
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parturient scheduled for elective spinal anesthetic for caesarean section.
- Resident level PGY1 or PGY2.
- Resident experience between 2-25 spinal anesthetics.
- ASA 1-3 scheduled for elective sections
Who cannot join
- Parturient BMI > 40.
- Emergency C-section.
- Previous spinal surgery or scoliosis.
- Parturient refusal
- Resident refusal
- Multiple gestations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of US Assistance for Anesthesia Trainees for Spinal Placement in Parturients Having Caesarean Section: A Randomized Control Trial
Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back.
Read the detailed description
Parturients receiving spinal anesthetic for elective Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back, prior to spinal insertion by anesthesia trainees.
The hypothesis is that ultrasound visualization of the patient spinal spaces will allow junior residents to correctly place the spinal needle with fewer attempts.
The null hypothesis is that there is no difference in the primary outcome (number of attempts). i.e. the investigators hypothesize that the number of attempts is not affected by ultrasound assistance. The control group will undergo spinal anesthesia with manual palpation, the standard of care.
- Conditions
- Pregnancy
- Being tested
- Ultrasound examination
- Keywords
- pregnancy, Caesarian, section, spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationDevice
Also called M-turbo
Trainees will receive pre-procedure U/S guided examination of the parturient's back.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Trainees will receive pre-procedure U/S guided examination of the parturient's back. Receives: Device: Ultrasound examination |
| Control | No intervention | Control group. (Standard practice) Trainees will NOT receive pre-procedure U/S guided examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts at intrathecal needle tip placement during spinal anesthesia.
Measured: Day 1
Secondary outcomes (4)
1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).
Measured: Day 1
Space used for 1st attempt, as estimated by palpation or U/S
Measured: Day 1
Number of spaces used
Measured: Day 1
Dural depth (cm)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Turkstra, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Timothy P Turkstra, M. Eng, MD, Principal investigator, UWO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444638
- Sponsor's protocol ID
- R-10-594
- Other IDs
- 17529
- Status last verified
- Jan 2013
- First submitted
- 3 Aug 2011
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of US Assistance for Anesthesia Trainees for Spinal Placement in Parturients Having Caesarean Section: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01444638
- Acronym / sponsor ID
- R-10-594
- Conditions
- Pregnancy
- Keywords
- pregnancy, Caesarian, section, spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Oct 2011 (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.
Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back.
Detailed description
Parturients receiving spinal anesthetic for elective Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back, prior to spinal insertion by anesthesia trainees.
The hypothesis is that ultrasound visualization of the patient spinal spaces will allow junior residents to correctly place the spinal needle with fewer attempts.
The null hypothesis is that there is no difference in the primary outcome (number of attempts). i.e. the investigators hypothesize that the number of attempts is not affected by ultrasound assistance. The control group will undergo spinal anesthesia with manual palpation, the standard of care.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Ultrasound examinationTrainees will receive pre-procedure U/S guided examination of the parturient's back. |
| Control | No intervention | –Control group. (Standard practice) Trainees will NOT receive pre-procedure U/S guided examination. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parturient scheduled for elective spinal anesthetic for caesarean section.
- Resident level PGY1 or PGY2.
- Resident experience between 2-25 spinal anesthetics.
- ASA 1-3 scheduled for elective sections
Key exclusion criteria (6 listed)
- Parturient BMI > 40.
- Emergency C-section.
- Previous spinal surgery or scoliosis.
- Parturient refusal
- Resident refusal
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 |
|---|---|---|
| Ultrasound examinationAlso: M-turboTrainees will receive pre-procedure U/S guided examination of the parturient's back. | Device | Ultrasound |
Primary outcome
Number of attempts at intrathecal needle tip placement during spinal anesthesia.
Time frame: Day 1
4 secondary outcomes
1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).
Time frame: Day 1
Space used for 1st attempt, as estimated by palpation or U/S
Time frame: Day 1
Number of spaces used
Time frame: Day 1
Dural depth (cm)
Time frame: Day 1
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 15 Jan 2013.
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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.
Timothy P Turkstra, M. Eng, MD principal investigator
UWO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound examination in people with Pregnancy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 4 inclusion and 6 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 15 Jan 2013. 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?
Number of attempts at intrathecal needle tip placement during spinal anesthesia. (time frame: Day 1). 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 15 Jan 2013.