Volume ResponsivenessNCT04614701
Correlation of Carotid Flow Time and Cardiac Output.
An observational study of Volume Responsiveness, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
Assessment of common carotid artery flow is more easily done and can be taught more broadly than transthoracic echocardiography, providing a greater number of clinicians a tool to assess volume responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Volume Responsiveness
- What is being tested?
- Carotid Artery Ultrasound Measure
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 31 Mar 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 80 years
- All sexes
- Adult, Older adult
Study population: 20 adult (age 18-80) patients admitted to the hospital with COVID-19 requiring supplemental oxygen, up to 6L, willing to undergo transthoracic and right carotid ultrasonography.
Who may be able to join
- Adult patient admitted to hospital with diagnosed COVID-19, on up to 6L oxygen, and able to undergo leg compression testing and passive leg raise.
Who cannot join
- known cardiac disease, carotid atherosclerosis, prior right-sided neck surgery, chest wall deformity, or deep-venous thrombosis identified on admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Carotid Flow Time and Cardiac Output With Preload Augmentation in Patients With COVID-19.
Assessment of common carotid artery flow is more easily done and can be taught more broadly than transthoracic echocardiography, providing a greater number of clinicians a tool to assess volume responsiveness. These assessments are of great importance to patients with COVID-19, who often present with hypotension requiring fluids, which must be balanced against limiting fluid administration to minimize pulmonary edema.
Read the detailed description
Optimizing volume status for patients in shock is of critical importance to their outcomes, both in the provision of helpful, and avoidance of harmful fluid volumes. As such, much work has been done to develop and assess measures of volume responsiveness; that is, tests that indicate whether additional fluid administration will increase cardiac output by at least 10%. The passive leg raise (PLR) providing a reversible "auto-bolus" has been demonstrated to be the most predictive assessment of fluid responsiveness.
Recent studies of changes in carotid artery blood flow suggest it can be used as a surrogate for changes in cardiac output with moderate reliability. This has been assessed in several populations with anticipated changes in volume status (e.g. before/after blood donation), and more recently assessed by Sidor et al. against several preload augmenting maneuvers. Interestingly, while decreasing preload resulted in a decrease in cardiac output and systolic carotid blood flow, it did not result in a decrease in corrected carotid flow time, although a PLR produced an expected increase in all measures.
In our study we seek to validate these results, questioning if there is a lower limit of corrected carotid flow time that de-couples the relationship between carotid systolic flow and corrected carotid flow time.
- Conditions
- Volume Responsiveness
- Being tested
- Carotid Artery Ultrasound Measure
- Keywords
- volume responsiveness, ultrasound, fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery Ultrasound MeasureProcedure or surgery
Cardiac output will be assessed by measuring the LVOT diameter in parasternal long-axis window and the LVOT VTI in apical-four window. Carotid artery flow will be measured on the right neck 1-2cm from the bifurcation of the common carotid artery. All measurements will be taken with participants supine and the head of the bed elevated to 45°. measures all at 3 minute intervals.
- One-leg compression test: Thigh-sized blood pressure cuff inflated to 60mmHg on middle part of one thigh for 60 seconds. LVOT and CCA measurements taken separately.
- Two-leg compression test: Thigh-sized blood pressure cuff inflated on middle part of both thighs for 60 seconds. LVOT and CCA measurements taken separately.
- Passive leg raise test: Bed adjusted to place participant at 0° and legs elevated at 45° by use of pillows. After 1 minute, measurements repeated. LVOT and CCA measurements taken separately.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured LVOT VTI by bedside echocardiography
Measurements for this parameter will be obtained at baseline, following one-leg and two-leg compression tests, and following passive leg raise
Measured: Through study completion, up to 1 year
Changed in corrected carotid artery flow time as measured by bedside carotid artery ultrasonography.
Measurements for this parameter will be obtained at baseline, following one-leg and two-leg compression tests, and following passive leg raise.
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: The co and principal investigator, due to limited resources and timing, have decided to withdrawal the study and close.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume ResponsivenessStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Rakesh C Arora, MD, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614701
- Sponsor's protocol ID
- HS24296
- Status last verified
- Jun 2022
- First submitted
- 21 Oct 2020
- Last updated
- 27 Jun 2022
- 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 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Carotid Flow Time and Cardiac Output With Preload Augmentation in Patients With COVID-19.
- ClinicalTrials.gov ID
- NCT04614701
- Acronym / sponsor ID
- HS24296
- Conditions
- Volume Responsiveness
- Keywords
- volume responsiveness, ultrasound, fluid responsiveness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The co and principal investigator, due to limited resources and timing, have decided to withdrawal the study and close.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 4 Nov 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.
Assessment of common carotid artery flow is more easily done and can be taught more broadly than transthoracic echocardiography, providing a greater number of clinicians a tool to assess volume responsiveness. These assessments are of great importance to patients with COVID-19, who often present with hypotension requiring fluids, which must be balanced against limiting fluid administration to minimize pulmonary edema.
Detailed description
Optimizing volume status for patients in shock is of critical importance to their outcomes, both in the provision of helpful, and avoidance of harmful fluid volumes. As such, much work has been done to develop and assess measures of volume responsiveness; that is, tests that indicate whether additional fluid administration will increase cardiac output by at least 10%. The passive leg raise (PLR) providing a reversible "auto-bolus" has been demonstrated to be the most predictive assessment of fluid responsiveness.
Recent studies of changes in carotid artery blood flow suggest it can be used as a surrogate for changes in cardiac output with moderate reliability. This has been assessed in several populations with anticipated changes in volume status (e.g. before/after blood donation), and more recently assessed by Sidor et al. against several preload augmenting maneuvers. Interestingly, while decreasing preload resulted in a decrease in cardiac output and systolic carotid blood flow, it did not result in a decrease in corrected carotid flow time, although a PLR produced an expected increase in all measures.
In our study we seek to validate these results, questioning if there is a lower limit of corrected carotid flow time that de-couples the relationship between carotid systolic flow and corrected carotid flow time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 20 adult (age 18-80) patients admitted to the hospital with COVID-19 requiring supplemental oxygen, up to 6L, willing to undergo transthoracic and right carotid ultrasonography.
Key inclusion criteria (1 listed)
- Adult patient admitted to hospital with diagnosed COVID-19, on up to 6L oxygen, and able to undergo leg compression testing and passive leg raise.
Key exclusion criteria (1 listed)
- known cardiac disease, carotid atherosclerosis, prior right-sided neck surgery, chest wall deformity, or deep-venous thrombosis identified on admission
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 |
|---|---|---|
| Carotid Artery Ultrasound MeasureCardiac output will be assessed by measuring the LVOT diameter in parasternal long-axis window and the LVOT VTI in apical-four window. Carotid artery flow will be measured on the right neck 1-2cm from the bifurcation of the common carotid artery. All measurements will be taken with participants supine and the head of the bed elevated to 45°. measures all at 3 minute intervals. 1. One-leg compression test: Thigh-sized blood pressure cuff inflated to 60mmHg on middle part of one thigh for 60 seconds. LVOT and CCA measurements taken separately. 2. Two-leg compression test: Thigh-sized blood pressure cuff inflated on middle part of both thighs for 60 seconds. LVOT and CCA measurements taken separately. 3. Passive leg raise test: Bed adjusted to place participant at 0° and legs elevated at 45° by use of pillows. After 1 minute, measurements repeated. LVOT and CCA measurements taken separately. | Procedure or surgery | – |
Primary outcome
Change in measured LVOT VTI by bedside echocardiography
Time frame: Through study completion, up to 1 year
Measurements for this parameter will be obtained at baseline, following one-leg and two-leg compression tests, and following passive leg raise
Changed in corrected carotid artery flow time as measured by bedside carotid artery ultrasonography.
Time frame: Through study completion, up to 1 year
Measurements for this parameter will be obtained at baseline, following one-leg and two-leg compression tests, and following passive leg raise.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Volume Responsiveness
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
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This Study Compares Two Noninvasive Dynamic Tools: Lung Ultrasound and Transthoracic Echocardiography Using LVOT VTI. It Aims to Measure the Sensitivity and Specificity of LUS in Guiding Fluid Resuscitation and Early Detection of Fluid Responsiveness and to Prevent Volume Overload
Septic Shock, Fluid Reponsiveness
RecruitingObservational study
Perceptions and Ultrasound Literacy for Sound Volume Management
Ultrasound-guided Fluid Management, Volume Responsiveness
Not yet recruitingObservational study
Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance
Venous Congestion
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Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
Circulatory Failure, Shock State
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.
Rakesh C Arora, MD principal investigator
St. Boniface 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 Volume Responsiveness, run by St. Boniface 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 1 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: withdrawn, as of the sponsor's last update on 27 Jun 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in measured LVOT VTI by bedside echocardiography (time frame: Through study completion, up to 1 year). 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 27 Jun 2022.