Pregnant WomenNCT03128541
Influence of Body Positioning on the Identification of Tuffier's Line Using the Palpation Method: An Ultrasound Study
An observational study of Pregnant Women, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study aims to ascertain whether being placed in a sitting or lateral decubitus position, influences identification of the midpoint of the L4/L5 intervertebral space, using manual demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral decubitus position. Read more about this study
- Who is it for?
- Ages 16 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Ultrasound spine
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2017to Dec 2017
- How long will I take part?
- 1 Day
- 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 16 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant parturients in the third trimester.
Who may be able to join
- >37 weeks gestation
- BMI<40
- Singleton pregnancy
- Aged 16 to 65 years old.
- Latent phase of labour (<4cm cervix dilatation).
Who cannot join
- Previous spinal surgery
- Scoliosis
- Age<16
- Patient unable to tolerate positions
- Degenerative disease of the spine
- Patient refusal or inability to provide informed consent
- Patient in established labour (i.e. >4cm cervical dilatation)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas' Hospital
London, SE1 7EH
Nhathien Nguyen-Lu, BMedSci(Hons) BMBS FRCA, 0207 188 7188 ext. 80652, nat.nguyen-lu@gstt.nhs.uk
About this study
Official title: Influence of Body Positioning on the Identification of Tuffier's Line Using the Traditional Palpation Method: An Ultrasound Study.
The study aims to ascertain whether being placed in a sitting or lateral decubitus position, influences identification of the midpoint of the L4/L5 intervertebral space, using manual demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using anatomical palpation and compared to the "true" mid-point measured by ultrasound. The procedure will be repeated in both positions on the same participant.The study will be a prospective, randomized, double blinded, crossover trial
Read the detailed description
Anaesthetists insert epidurals or spinal anaesthetics (collectively called central neuraxial blocks) to patients during childbirth to provide pain relief and anaesthesia. A spinal anaesthetic involves the injection of pain relieving medicines directly into the sac of fluid that surrounds the spinal cord. An epidural uses a different technique to place a thin plastic tube into the fatty tissues that surround this sac. Spinal anaesthesia must be placed below where the spinal cord ends to avoid nerve trauma. Doctors have traditionally been taught to identify a safe level, by feeling the top of a patients hips and drawing an imaginary line between these two points across the patients back known as Tuffier's line. This identifies L4/5 interspace, below which anaesthetists avoids the termination of the spinal cord. The same blind "anatomical rule" is used throughout anaesthetics, whether the patient is male or female, young or old, pregnant or non-pregnant, supine or lateral, an approach that is clearly far from robust. The physiological changes of pregnancy such as fluid retention and weight gain can further make identification of the standard landmarks challenging. Advances in ultrasound technology have allowed direct visualisation of the bones in the back. Studies have shown that the conventional anatomical based method for locating the point of needle insertion is unreliable even amongst experienced anaesthetists.
Spinal or epidural anaesthesia can be performed with the patient either sitting or lying on their side. The investigators aim to determine whether a difference exists between the perceived mid-point of the L4/L5 intervertebral space, identified using manual demarcation of Tuffier's line, in these two positions. Ultrasound will then be used to ascertain the distance from the "true" midpoint.
- Conditions
- Pregnant Women
- Being tested
- Ultrasound spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound spineDiagnostic test
A ultrasound of the lumbar spine of each patient will be performed in both positions to identify vertebral levels
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Spine in sitting position | Participants will be assigned to a sitting decubitus position to identify the Tuffier's Line Receives: Diagnostic Test: Ultrasound spine | |
| Ultrasound Spine in lateral position | Participants will be assigned to a lateral decubitus position to identify the Tuffier's Line Receives: Diagnostic Test: Ultrasound spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrepancy in distance between palpation vs. ultrasound midpoint of L4/5. interspace.
Distance (mm) between the mid-point of the L4/L5 intervertebral space in sitting and lateral decubitus positions, identified through manual palpation compared to the "true" mid-point measured by ultrasound.
Measured: 15-30 minutes
Secondary outcomes (1)
Discrepancy in distance between ultrasound midpoint of L4/5 in sitting vs. lateral position
Distance (mm) between the mid-point of the L4/L5 intervertebral space identified by ultrasound in sitting versus lateral decubitus positions.
Measured: 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start14 Apr 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nhathien Nguyen-Lu, FRCA, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128541
- Sponsor's protocol ID
- 218764
- Status last verified
- Jul 2017
- First submitted
- 20 Apr 2017
- Last updated
- 1 Aug 2017
- 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 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Body Positioning on the Identification of Tuffier's Line Using the Traditional Palpation Method: An Ultrasound Study.
- ClinicalTrials.gov ID
- NCT03128541
- Acronym / sponsor ID
- 218764
- Conditions
- Pregnant Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Apr 2017 (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 study aims to ascertain whether being placed in a sitting or lateral decubitus position, influences identification of the midpoint of the L4/L5 intervertebral space, using manual demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using anatomical palpation and compared to the "true" mid-point measured by ultrasound. The procedure will be repeated in both positions on the same participant.The study will be a prospective, randomized, double blinded, crossover trial
Detailed description
Anaesthetists insert epidurals or spinal anaesthetics (collectively called central neuraxial blocks) to patients during childbirth to provide pain relief and anaesthesia. A spinal anaesthetic involves the injection of pain relieving medicines directly into the sac of fluid that surrounds the spinal cord. An epidural uses a different technique to place a thin plastic tube into the fatty tissues that surround this sac. Spinal anaesthesia must be placed below where the spinal cord ends to avoid nerve trauma. Doctors have traditionally been taught to identify a safe level, by feeling the top of a patients hips and drawing an imaginary line between these two points across the patients back known as Tuffier's line. This identifies L4/5 interspace, below which anaesthetists avoids the termination of the spinal cord. The same blind "anatomical rule" is used throughout anaesthetics, whether the patient is male or female, young or old, pregnant or non-pregnant, supine or lateral, an approach that is clearly far from robust. The physiological changes of pregnancy such as fluid retention and weight gain can further make identification of the standard landmarks challenging. Advances in ultrasound technology have allowed direct visualisation of the bones in the back. Studies have shown that the conventional anatomical based method for locating the point of needle insertion is unreliable even amongst experienced anaesthetists.
Spinal or epidural anaesthesia can be performed with the patient either sitting or lying on their side. The investigators aim to determine whether a difference exists between the perceived mid-point of the L4/L5 intervertebral space, identified using manual demarcation of Tuffier's line, in these two positions. Ultrasound will then be used to ascertain the distance from the "true" midpoint.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Spine in sitting position | – | Diagnostic Test: Ultrasound spineParticipants will be assigned to a sitting decubitus position to identify the Tuffier's Line |
| Ultrasound Spine in lateral position | – | Diagnostic Test: Ultrasound spineParticipants will be assigned to a lateral decubitus position to identify the Tuffier's Line |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant parturients in the third trimester.
Key inclusion criteria (5 listed)
- >37 weeks gestation
- BMI<40
- Singleton pregnancy
- Aged 16 to 65 years old.
- Latent phase of labour (<4cm cervix dilatation).
Key exclusion criteria (7 listed)
- Previous spinal surgery
- Scoliosis
- Age<16
- Patient unable to tolerate positions
- Degenerative disease of the spine
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 spineA ultrasound of the lumbar spine of each patient will be performed in both positions to identify vertebral levels | Diagnostic test | Ultrasound Spine in lateral position, Ultrasound Spine in sitting position |
Primary outcome
Discrepancy in distance between palpation vs. ultrasound midpoint of L4/5. interspace.
Time frame: 15-30 minutes
Distance (mm) between the mid-point of the L4/L5 intervertebral space in sitting and lateral decubitus positions, identified through manual palpation compared to the "true" mid-point measured by ultrasound.
1 secondary outcome
Discrepancy in distance between ultrasound midpoint of L4/5 in sitting vs. lateral position
Time frame: 15-30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- 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.
Nhathien Nguyen-Lu, FRCA principal investigator
Guy's and St Thomas' NHS Foundation Trust
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 Pregnant Women, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 7 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 Aug 2017. 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 Kingdom. 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 Nhathien Nguyen-Lu, FRCA (0207 188 7188 ext. 80652, nat.nguyen-lu@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discrepancy in distance between palpation vs. ultrasound midpoint of L4/5. interspace. (time frame: 15-30 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 Aug 2017.