Hemodynamic InstabilityNCT05227729
Descending Aorta Blood Flow to Guide Fluid Therapy During Surgery
An observational study of Hemodynamic Instability, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
The investigators will perform a clinical observational study of patients undergoing abdominal surgery. The study will be performed at Sykehuset Telemark, Skien. The aims of the study are to compare suprasternal and transoesophageal Doppler (reference method) to measure blood flow in the proximal descending aorta and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler technique and Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler technique
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 18 Oct 2022to 29 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that plan to undergo abdominal surgery (gastrointestinal or gynecological) at Telemark hospital, Skien, Norway.
Who may be able to join
- Patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 h estimated duration.
- The patients should be of American Society of Anesthesiologists physical status 1-3
Who cannot join
- Pathology in the larynx, oesophagus or stomach
- Former surgery in larynx, oesophagus or stomach
- Thoracic aortic aneurysm.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will perform a clinical observational study of patients undergoing abdominal surgery. The study will be performed at Sykehuset Telemark, Skien. The aims of the study are to compare suprasternal and transoesophageal Doppler (reference method) to measure blood flow in the proximal descending aorta and to explore the variability of hemodynamic variables during surgery.
Read the detailed description
Background and aim: The best validated method to estimate cardiac output with ultrasound requires measuring the Doppler velocity time integral (VTI) in the left ventricular outflow tract measured from the apical (lateral chest) window/ projection. However, this projection is often out of reach for anaesthesiologists during many surgical procedures (e.g. abdominal surgery) due to draping, and is often difficult to perform if the patient cannot be placed in the left lateral decubitus position. Alternatively, VTI in the proximal descending aorta may be measured via the suprasternal view, which is one of the standard projections in transthoracic echocardiography. This view is often available for anaesthesiologists during surgery on a patient in supine position. Assuming that changes in cardiac output are associated with changes in VTI in proximal descending aorta, this may provide the anaesthesiologist with a non-invasive measure of the response to a fluid challenge. The first aim of this study is to evaluate the ability of suprasternal Doppler to measure blood flow in the proximal descending aorta, and its agreement with the reference method oesophageal Doppler, during ongoing abdominal surgery.
Fluid challenges are typically given when stroke volume is reduced by 10-15%, which is considered a significant reduction. This is however dependent on the precision of the measurements, which is estimated during hemodynamic stability. During surgery, on the other hand, the variability may be larger, leading to erroneously concluding that stroke volume is reduced due to volume loss, when in fact this may be due to other stimuli related to surgery (mechanical, e.g. compression of large veins or the thoracic cavity, or stimuli affecting the autonomic nervous system, e.g. pain). The proportion of potentially falsely measured reduction may be calculated by performing repeated measurements during ongoing surgery. Thus, an other aim with this study is to explore the variability of measurements of stroke volume during surgery.
Study design: Clinical observational study.
Data collection: 30 patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 hrs estimated duration. The patients should be of American Society of Anesthesiologists physical status 1-3 and have no contraindications to the use of oesophageal ultrasound. Hemodynamic data will be downloaded to a PC continuously from the clinical monitoring equipment (Philips Intellivue) using the VSCapture software (https://github.com/xeonfusion/VSCaptureMP) in VisualStudio (Microsoft). "Landmarks" in the procedure (e.g. surgical incision, manipulation in the surgical field and hemorrhage) will be recorded manually to relate the hemodynamic data to the different steps in the procedure. Blood flow velocity in the descending aorta will be measured using ultrasound machines in ordinary clinical use (GE Venue R 2.5; GE Healthcare). The Doppler recordings will be analyzed using commercially available software (EchoPAC; General Electric) after blinding.
Data analyzes:
- Considerations regarding sample size for agreement analyzes: The investigators will focus on within-subject variability, and the main outcome will be the corresponding within-subject limits of agreement. If both methods have a precision of 2.9%, limits of agreement will be 8.3%. Given 18 measurements per subject (one measurement every 5 min over 1.5 hrs), 25 subjects will give an 80% power for an upper confidence interval of the limits of agreement of 18%. By including 30 patients, the investigators allow for some unsuccessful measurements due to e.g. poor echogenicity.
- Considerations regarding sample size for variability analyzes: Given that the SD of oesophageal Doppler is 2.9%, the precision is 2.9%×1.96=5.7%. The probability of each evaluation of showing a false reduction is 0.8%. If surgery lasts 1.5 hrs with one evaluation every 5 min, the probability of at least one false reduction is 12%. If the precision is reduced with a doubled SD, the probability of at least one false reduction is 88%. Assuming a true SD of 2.9%; studying 25 subjects gives a power of 0.8 to detect a SD <3.0%.
- Conditions
- Hemodynamic Instability
- Being tested
- Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler technique, Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler technique
- Keywords
- Hemodynamics, Blood Circulation, Aorta, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler techniqueDiagnostic test
While study subjects are in general anesthesia the investigator will perform repeated measurements every 5 min.
Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler techniqueDiagnostic test
While study subjects are in general anesthesia the investigator will perform repeated measurements every 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing abdominal surgery | Inclusion criteria: > 18 years old, American Society of Anesthesiologists physical status 1-3, abdominal surgery of > 1,5 hrs estimated duration, no contraindications to the use of oesophageal ultrasound. Receives: Diagnostic Test: Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler technique; Diagnostic Test: Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood flow velocity in descending aorta
Suprasternal Doppler
Measured: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Change in blood flow velocity in descending aorta
Transoesophageal Doppler
Measured: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Change in stroke volume
Calculated from the measurements by transoesophageal Doppler
Measured: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Secondary outcomes (3)
Change in heart rate
Measured in beats per minute, collected from standard monitoring device during surgery
Measured: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Change in systemic vascular resistance
Measured in dynes/second/cm^5. Calculated from the measurements by transoesophageal Doppler and standard monitoring device (mean arterial pressure)
Measured: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Change in blood pressure
Measured in mmHg, collected from standard monitoring device during surgery
Measured: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start18 Oct 2022
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, University of Oslo
- Responsible party
- Principal investigator, Torkjell Nostdahl, Sykehuset Telemark
- Investigators
- Torkjell Nøstdahl, MD, PhD, Principal investigator, Telemark Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227729
- Sponsor's protocol ID
- 264472
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2021
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descending Aorta Blood Flow to Guide Fluid Therapy During Surgery
- ClinicalTrials.gov ID
- NCT05227729
- Acronym / sponsor ID
- 264472
- Conditions
- Hemodynamic Instability
- Keywords
- Hemodynamics, Blood Circulation, Aorta, Thoracic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Oslo University Hospital, University of Oslo
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 7 Feb 2022 (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 investigators will perform a clinical observational study of patients undergoing abdominal surgery. The study will be performed at Sykehuset Telemark, Skien. The aims of the study are to compare suprasternal and transoesophageal Doppler (reference method) to measure blood flow in the proximal descending aorta and to explore the variability of hemodynamic variables during surgery.
Detailed description
Background and aim: The best validated method to estimate cardiac output with ultrasound requires measuring the Doppler velocity time integral (VTI) in the left ventricular outflow tract measured from the apical (lateral chest) window/ projection. However, this projection is often out of reach for anaesthesiologists during many surgical procedures (e.g. abdominal surgery) due to draping, and is often difficult to perform if the patient cannot be placed in the left lateral decubitus position. Alternatively, VTI in the proximal descending aorta may be measured via the suprasternal view, which is one of the standard projections in transthoracic echocardiography. This view is often available for anaesthesiologists during surgery on a patient in supine position. Assuming that changes in cardiac output are associated with changes in VTI in proximal descending aorta, this may provide the anaesthesiologist with a non-invasive measure of the response to a fluid challenge. The first aim of this study is to evaluate the ability of suprasternal Doppler to measure blood flow in the proximal descending aorta, and its agreement with the reference method oesophageal Doppler, during ongoing abdominal surgery.
Fluid challenges are typically given when stroke volume is reduced by 10-15%, which is considered a significant reduction. This is however dependent on the precision of the measurements, which is estimated during hemodynamic stability. During surgery, on the other hand, the variability may be larger, leading to erroneously concluding that stroke volume is reduced due to volume loss, when in fact this may be due to other stimuli related to surgery (mechanical, e.g. compression of large veins or the thoracic cavity, or stimuli affecting the autonomic nervous system, e.g. pain). The proportion of potentially falsely measured reduction may be calculated by performing repeated measurements during ongoing surgery. Thus, an other aim with this study is to explore the variability of measurements of stroke volume during surgery.
Study design: Clinical observational study.
Data collection: 30 patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 hrs estimated duration. The patients should be of American Society of Anesthesiologists physical status 1-3 and have no contraindications to the use of oesophageal ultrasound. Hemodynamic data will be downloaded to a PC continuously from the clinical monitoring equipment (Philips Intellivue) using the VSCapture software (https://github.com/xeonfusion/VSCaptureMP) in VisualStudio (Microsoft). "Landmarks" in the procedure (e.g. surgical incision, manipulation in the surgical field and hemorrhage) will be recorded manually to relate the hemodynamic data to the different steps in the procedure. Blood flow velocity in the descending aorta will be measured using ultrasound machines in ordinary clinical use (GE Venue R 2.5; GE Healthcare). The Doppler recordings will be analyzed using commercially available software (EchoPAC; General Electric) after blinding.
Data analyzes:
- Considerations regarding sample size for agreement analyzes: The investigators will focus on within-subject variability, and the main outcome will be the corresponding within-subject limits of agreement. If both methods have a precision of 2.9%, limits of agreement will be 8.3%. Given 18 measurements per subject (one measurement every 5 min over 1.5 hrs), 25 subjects will give an 80% power for an upper confidence interval of the limits of agreement of 18%. By including 30 patients, the investigators allow for some unsuccessful measurements due to e.g. poor echogenicity.
- Considerations regarding sample size for variability analyzes: Given that the SD of oesophageal Doppler is 2.9%, the precision is 2.9%×1.96=5.7%. The probability of each evaluation of showing a false reduction is 0.8%. If surgery lasts 1.5 hrs with one evaluation every 5 min, the probability of at least one false reduction is 12%. If the precision is reduced with a doubled SD, the probability of at least one false reduction is 88%. Assuming a true SD of 2.9%; studying 25 subjects gives a power of 0.8 to detect a SD <3.0%.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing abdominal surgery | – | Diagnostic Test: Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler technique, Diagnostic Test: Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler techniqueInclusion criteria: > 18 years old, American Society of Anesthesiologists physical status 1-3, abdominal surgery of > 1,5 hrs estimated duration, no contraindications to the use of oesophageal ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that plan to undergo abdominal surgery (gastrointestinal or gynecological) at Telemark hospital, Skien, Norway.
Key inclusion criteria (2 listed)
- Patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 h estimated duration.
- The patients should be of American Society of Anesthesiologists physical status 1-3
Key exclusion criteria (3 listed)
- Pathology in the larynx, oesophagus or stomach
- Former surgery in larynx, oesophagus or stomach
- Thoracic aortic aneurysm.
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 |
|---|---|---|
| Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler techniqueWhile study subjects are in general anesthesia the investigator will perform repeated measurements every 5 min. | Diagnostic test | Patients undergoing abdominal surgery |
| Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler techniqueWhile study subjects are in general anesthesia the investigator will perform repeated measurements every 5 min. | Diagnostic test | Patients undergoing abdominal surgery |
Primary outcome
Change in blood flow velocity in descending aorta
Time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Suprasternal Doppler
Change in blood flow velocity in descending aorta
Time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Transoesophageal Doppler
Change in stroke volume
Time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Calculated from the measurements by transoesophageal Doppler
3 secondary outcomes
Change in heart rate
Time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Change in systemic vascular resistance
Time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours
Change in blood pressure
Time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours
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 25 Apr 2024.
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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.
Torkjell Nøstdahl, MD, PhD principal investigator
Telemark Hospital 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 Hemodynamic Instability, run by Sykehuset Telemark at 1 site in Norway.
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 2 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 25 Apr 2024. 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 Norway. 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?
Change in blood flow velocity in descending aorta (time frame: During surgery, every 5 minutes. At least over a time period of 1,5 hours). The study lists 3 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 25 Apr 2024.