Vascular StiffnessNCT03237429
The Relationship Between BCM, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia
An observational study of Vascular Stiffness and Hypotension on Induction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Arterial hypotension during induction of general anesthesia is a risk factor for developing postoperative cardiovascular complications. After induction of general anesthesia patients have a high risk of developing arterial hypotension due to anesthetic drugs who can depress cardiac contractility and determine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness, Hypotension on Induction, Anesthesia; Reaction
- What is being tested?
- bioimpedance spectroscopy
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- 3 Jan 2017to 1 Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients scheduled for surgery for a new diagnosed cancer pathology
Who may be able to join
- patients scheduled for surgery for a new diagnosed cancer pathology
Who cannot join
- diabetes (on insulin therapy),
- renal insufficiency (creatinine>2.0mg/dl),
- history of arterial bypass, carotid endoarterectomy,
- history of atrial fibrillation/flutter, ischemic stroke, transient ischemic attack, myocardial infarction or coronary revascularization (any type) within 6 months,
- known left main or 3-vessel coronary disease positive myocardial perfusion study without subsequent revascularization,
- heart failure (>3 NYHA) class 3, known left ventricle ejection fraction <30%, pulmonary hypertension (PA systolic >50mmHg), right ventricle dysfunction,
Show all 9Show fewer
- sepsis,
- pregnancy,
- limb amputation.
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Regional Institute of Oncology, Iasi
Iași
Ianis Siriopol, +o746215967, ianis.siriopol@gmail.com
About this study
Official title: The Relationship Between Volemic Status as Assessed by Bioimpedance Spectroscopy, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia
Arterial hypotension during induction of general anesthesia is a risk factor for developing postoperative cardiovascular complications. After induction of general anesthesia patients have a high risk of developing arterial hypotension due to anesthetic drugs who can depress cardiac contractility and determine vasodilatation. Previous studies have shown that even short periods of hypotension with a mean arterial pressure of less than 55 mmHg during surgery is associated with an increased incidence of cardiac injury and acute kidney injury in the postoperative period.
The volemic status of the patients in the preoperative period is very difficult to quantify and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting. Bioimpedance is recognized by over 30 years as a simple and non invasive technique to determine the volemic status especially in the hemodialysed patients. A new device BCM- Body Composition Monitoring (Fresenius Medical Care) offers a simple method to determine extracellular water and total body water. These volumes are determined by measuring impedance at 50 different frequencies thru electrodes placed at the ankle and wrist. BCM can also determine lean tissue mass and adipose tissue mass.
Read more
Increasing arterial stiffness is the main characteristic of arterial aging; this increase determines the increase of the afterload, left ventricular hypertrophy, the decrease of coronary and tissue perfusion. Arterial applanation tonometry is a non-invasive technique that has been shown to reliably provide indices of arterial stiffness.
In this study investigators wish to determine if there is a correlation between the hidric status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia. The measurements will be obtained before induction of general anesthesia in the pre-surgical area. During induction of general anesthesia with standard induction agents and Bispectral index monitoring, brachial blood pressure will be measured by a cuff every minute after the loss of verbal contact with the patient up to ten minutes after tracheal intubation. A hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below 55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the patient before the surgery.
Measurement of the hidric status and aortic stiffness may represent a valid indicator of the risk of hypotension during anesthesia induction.
Read the detailed description
Arterial hypotension during induction of general anesthesia is a risk factor for developing postoperative cardiovascular complications. After induction of general anesthesia patients have a high risk of developing arterial hypotension due to anesthetic drugs who can depress cardiac contractility and determine vasodilatation. Risk factors associated with increased incidence of arterial hypotension at induction of general anesthesia are age > 50 years, ASA risk class III or IV, using high doses of propofol or fetanyl at induction. Previous studies have shown that even short periods of hypotension with a mean arterial pressure of less than 55 mmHg during surgery is associated with an increased incidence of cardiac injury and acute kidney injury in the postoperative period. Even if it is known that arterial hypotension is associated with increased incidence of postoperative complications, the inferior limit and duration of hypotension is not well defined. The volemic status of the patients in the preoperative period is very difficult to quantify and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting. Bioimpedance is recognized by over 30 years as a simple and non invasive technique to determine the volemic status especially in the hemodialyzed patients. A new device BCM- Body Composition Monitoring (Fresenius Medical Care) offers a simple method to determine extracellular water and total body water. These volumes are determined by measuring impedance at 50 different frequencies thrue electrodes placed at the ankle and wrist. BCM can also determine lean tissue mass and adipose tissue mass.
Increasing arterial stiffness is the main characteristic of arterial aging; this increase determines the increase of the afterload, left ventricular hypertrophy, the decrease of coronary and tissue perfusion. Increased arterial stiffness is associated with altered ability of maintaining a normal arterial pressure during stress conditions; it is known the risk of orthostatic hypotension in older patients wits increased arterial stiffness Arterial applanation tonometry is asimple, non-invasive technique that has been shown to reliably provide indices of arterial stiffness. Measuring carotid-femural pulse wave velocity thrue applanation tonometry is considered the "gold standard" for measuring arterial stiffness.In this study carotid-femoral pulse wave velocity will be determined by applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery.
In this study investigators wish to determine if there is a correlation between the hidric status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia. The measurements will be obtained before induction of general anesthesia in the pre-surgical area. During induction of general anesthesia with standard induction agents(fentanyl propofol, rocuronium) and Bispectral index monitoring, brachial blood pressure will be measured by a cuff every minute after the loss of verbal contact with the patient up to ten minutes after tracheal intubation. A hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below 55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the patient before the surgery.
Study population : patients who are going under surgery. Inclusion criteria: there will be two study populations. The first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology. The second study population will represent patients scheduled for surgery not for cancer disease. Exclusion criteria: diabetes (on insulin therapy), renal insufficiency (creatinine>2.0mg/dl), history of arterial bypass), history of carotid endoarterectomy, atrial fibrillation/flutter, history of ischemic stroke, transient ischemic attack, myocardial infarction or coronary revascularization (any type) within 6 months, known left main or 3-vessel coronary disease positive myocardial perfusion study without subsequent revascularization, heart failure (>3 NYHA) class 3, known left ventricle ejection fraction <30%, pulmonary hypertension (PA systolic >50mmHg), right ventricle dysfunction, sepsis, pregnancy, limb amputation.
- Being tested
- bioimpedance spectroscopy
- Keywords
- bioimpedance spectroscopy, arterial stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioimpedance spectroscopyDiagnostic test
Also called Carotid-femoral pulse wave velocity
Bioimpedance spectroscopy-The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid.
Carotid-femoral pulse wave velocity-will be determined by arterial applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms.. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients | The first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology Receives: Diagnostic Test: bioimpedance spectroscopy | |
| non-cancer patients | The second study population will represent patients scheduled for surgery not for cancer disease Receives: Diagnostic Test: bioimpedance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia
Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia
Measured: 2 years
Correlation between arterial stiffness and hypotension during induction of general anesthesia
Correlation between the carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start3 Jan 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular StiffnessStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Dimitrie Siriopol, MD, PhD, Study chair, GRT POPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237429
- Sponsor's protocol ID
- GTPopaUMP
- Status last verified
- Feb 2019
- First submitted
- 30 Jul 2017
- Last updated
- 27 Feb 2019
- 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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Volemic Status as Assessed by Bioimpedance Spectroscopy, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT03237429
- Acronym / sponsor ID
- GTPopaUMP
- Keywords
- bioimpedance spectroscopy, arterial stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 2 Aug 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.
Arterial hypotension during induction of general anesthesia is a risk factor for developing postoperative cardiovascular complications. After induction of general anesthesia patients have a high risk of developing arterial hypotension due to anesthetic drugs who can depress cardiac contractility and determine vasodilatation. Previous studies have shown that even short periods of hypotension with a mean arterial pressure of less than 55 mmHg during surgery is associated with an increased incidence of cardiac injury and acute kidney injury in the postoperative period.
The volemic status of the patients in the preoperative period is very difficult to quantify and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting. Bioimpedance is recognized by over 30 years as a simple and non invasive technique to determine the volemic status especially in the hemodialysed patients. A new device BCM- Body Composition Monitoring (Fresenius Medical Care) offers a simple method to determine extracellular water and total body water. These volumes are determined by measuring impedance at 50 different frequencies thru electrodes placed at the ankle and wrist. BCM can also determine lean tissue mass and adipose tissue mass.
Increasing arterial stiffness is the main characteristic of arterial aging; this increase determines the increase of the afterload, left ventricular hypertrophy, the decrease of coronary and tissue perfusion. Arterial applanation tonometry is a non-invasive technique that has been shown to reliably provide indices of arterial stiffness.
In this study investigators wish to determine if there is a correlation between the hidric status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia. The measurements will be obtained before induction of general anesthesia in the pre-surgical area. During induction of general anesthesia with standard induction agents and Bispectral index monitoring, brachial blood pressure will be measured by a cuff every minute after the loss of verbal contact with the patient up to ten minutes after tracheal intubation. A hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below 55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the patient before the surgery.
Measurement of the hidric status and aortic stiffness may represent a valid indicator of the risk of hypotension during anesthesia induction.
Detailed description
Arterial hypotension during induction of general anesthesia is a risk factor for developing postoperative cardiovascular complications. After induction of general anesthesia patients have a high risk of developing arterial hypotension due to anesthetic drugs who can depress cardiac contractility and determine vasodilatation. Risk factors associated with increased incidence of arterial hypotension at induction of general anesthesia are age > 50 years, ASA risk class III or IV, using high doses of propofol or fetanyl at induction. Previous studies have shown that even short periods of hypotension with a mean arterial pressure of less than 55 mmHg during surgery is associated with an increased incidence of cardiac injury and acute kidney injury in the postoperative period. Even if it is known that arterial hypotension is associated with increased incidence of postoperative complications, the inferior limit and duration of hypotension is not well defined. The volemic status of the patients in the preoperative period is very difficult to quantify and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting. Bioimpedance is recognized by over 30 years as a simple and non invasive technique to determine the volemic status especially in the hemodialyzed patients. A new device BCM- Body Composition Monitoring (Fresenius Medical Care) offers a simple method to determine extracellular water and total body water. These volumes are determined by measuring impedance at 50 different frequencies thrue electrodes placed at the ankle and wrist. BCM can also determine lean tissue mass and adipose tissue mass.
Increasing arterial stiffness is the main characteristic of arterial aging; this increase determines the increase of the afterload, left ventricular hypertrophy, the decrease of coronary and tissue perfusion. Increased arterial stiffness is associated with altered ability of maintaining a normal arterial pressure during stress conditions; it is known the risk of orthostatic hypotension in older patients wits increased arterial stiffness Arterial applanation tonometry is asimple, non-invasive technique that has been shown to reliably provide indices of arterial stiffness. Measuring carotid-femural pulse wave velocity thrue applanation tonometry is considered the "gold standard" for measuring arterial stiffness.In this study carotid-femoral pulse wave velocity will be determined by applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery.
In this study investigators wish to determine if there is a correlation between the hidric status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia. The measurements will be obtained before induction of general anesthesia in the pre-surgical area. During induction of general anesthesia with standard induction agents(fentanyl propofol, rocuronium) and Bispectral index monitoring, brachial blood pressure will be measured by a cuff every minute after the loss of verbal contact with the patient up to ten minutes after tracheal intubation. A hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below 55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the patient before the surgery.
Study population : patients who are going under surgery. Inclusion criteria: there will be two study populations. The first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology. The second study population will represent patients scheduled for surgery not for cancer disease. Exclusion criteria: diabetes (on insulin therapy), renal insufficiency (creatinine>2.0mg/dl), history of arterial bypass), history of carotid endoarterectomy, atrial fibrillation/flutter, history of ischemic stroke, transient ischemic attack, myocardial infarction or coronary revascularization (any type) within 6 months, known left main or 3-vessel coronary disease positive myocardial perfusion study without subsequent revascularization, heart failure (>3 NYHA) class 3, known left ventricle ejection fraction <30%, pulmonary hypertension (PA systolic >50mmHg), right ventricle dysfunction, sepsis, pregnancy, limb amputation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer patients | – | Diagnostic Test: bioimpedance spectroscopyThe first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology |
| non-cancer patients | – | Diagnostic Test: bioimpedance spectroscopyThe second study population will represent patients scheduled for surgery not for cancer disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for surgery for a new diagnosed cancer pathology
Key inclusion criteria (1 listed)
- patients scheduled for surgery for a new diagnosed cancer pathology
Key exclusion criteria (9 listed)
- diabetes (on insulin therapy),
- renal insufficiency (creatinine>2.0mg/dl),
- history of arterial bypass, carotid endoarterectomy,
- history of atrial fibrillation/flutter, ischemic stroke, transient ischemic attack, myocardial infarction or coronary revascularization (any type) within 6 months,
- known left main or 3-vessel coronary disease positive myocardial perfusion study without subsequent revascularization,
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 |
|---|---|---|
| bioimpedance spectroscopyAlso: Carotid-femoral pulse wave velocityBioimpedance spectroscopy-The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid. Carotid-femoral pulse wave velocity-will be determined by arterial applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms.. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery. | Diagnostic test | cancer patients, non-cancer patients |
Primary outcome
Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia
Time frame: 2 years
Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia
Correlation between arterial stiffness and hypotension during induction of general anesthesia
Time frame: 2 years
Correlation between the carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
Dimitrie Siriopol, MD, PhD study chair
GRT POPA
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 Vascular Stiffness and Hypotension on Induction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 9 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 27 Feb 2019. 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 Romania. 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 Ianis Siriopol (+40746215967, ianis.siriopol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia (time frame: 2 years). 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 Feb 2019; AzTrials last refreshed its copy on 28 Oct 2026.