Carotid OcclusionNCT04173910
Carotid Artery Analysis During an LPEC Manoeuvre
An observational study of Carotid Occlusion, run by University of Liege at 1 site in Belgium.
Trial summary
Verify in ultrasound the impact of a Sellick and LPEC manoeuvre in terms of compression of the carotid artery and decrease in vascular flow. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carotid Occlusion
- What is being tested?
- Ultrasound LPEC/Sellick
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2020to 1 Aug 2020
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Adults
Who may be able to join
- Adults Volunteers
Who cannot join
- pregnant women
- people with carotid artery defects
- people with an anomaly in the oropharyngeal massif
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Left Paratracheal Compression of the Cervical Esophagus and the Sellick Manoeuvre on the Compressibility of the Carotid Artery and Its Possible Effects on the Vascular Flow
Verify in ultrasound the impact of a Sellick and LPEC manoeuvre in terms of compression of the carotid artery and decrease in vascular flow.
- Conditions
- Carotid Occlusion
- Being tested
- Ultrasound LPEC/Sellick
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound LPEC/SellickProcedure or surgery
We will perform an ultrasound of the carotid artery and then apply a Sellick manoeuvre and a left paratracheal compression of the cervical esophagus respectively.
| Study group | Role | What they receive |
|---|---|---|
| LPEC/Sellick ultrasound | Not described Receives: Procedure: Ultrasound LPEC/Sellick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compression of the carotid artery during an esophageal compression manoeuvre
Measurement of the diameter of the carotid artery in cross-section and longitudinal section
Measured: through study completion, an average of 1 month
Vascular flow of the carotid artery during an esophageal compression manoeuvre
Measurement of systolic velocities in pulsed Doppler in the carotid artery
Measured: through study completion, an average of 1 month
Secondary outcomes (1)
Measurement of the force to be applied to compress the esophagus without compressing the carotid artery
use of a dynamometer to measure the force required to exert at the left paratracheal level
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start15 Jun 2020
- Primary completion15 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid OcclusionStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173910
- Sponsor's protocol ID
- LPECarotide
- Status last verified
- Oct 2020
- First submitted
- 19 Nov 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Left Paratracheal Compression of the Cervical Esophagus and the Sellick Manoeuvre on the Compressibility of the Carotid Artery and Its Possible Effects on the Vascular Flow
- ClinicalTrials.gov ID
- NCT04173910
- Acronym / sponsor ID
- LPECarotide
- Conditions
- Carotid Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Nov 2019 (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.
Verify in ultrasound the impact of a Sellick and LPEC manoeuvre in terms of compression of the carotid artery and decrease in vascular flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPEC/Sellick ultrasound | – | Procedure: Ultrasound LPEC/Sellick |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (1 listed)
- Adults Volunteers
Key exclusion criteria (3 listed)
- pregnant women
- people with carotid artery defects
- people with an anomaly in the oropharyngeal massif
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 LPEC/SellickWe will perform an ultrasound of the carotid artery and then apply a Sellick manoeuvre and a left paratracheal compression of the cervical esophagus respectively. | Procedure or surgery | LPEC/Sellick ultrasound |
Primary outcome
Compression of the carotid artery during an esophageal compression manoeuvre
Time frame: through study completion, an average of 1 month
Measurement of the diameter of the carotid artery in cross-section and longitudinal section
Vascular flow of the carotid artery during an esophageal compression manoeuvre
Time frame: through study completion, an average of 1 month
Measurement of systolic velocities in pulsed Doppler in the carotid artery
1 secondary outcome
Measurement of the force to be applied to compress the esophagus without compressing the carotid artery
Time frame: through study completion, an average of 1 month
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 6 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carotid Occlusion, run by University of Liege at 1 site in Belgium.
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 6 Oct 2020. 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 Belgium. 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?
Compression of the carotid artery during an esophageal compression manoeuvre (time frame: through study completion, an average of 1 month). 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 6 Oct 2020.