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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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,
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  • sepsis,
  • pregnancy,
  • limb amputation.

Trial locations and contacts

1 site in 1 country.

Romania1 site, 1 recruiting
  • Regional Institute of Oncology, Iasi

    Iași

    Ianis Siriopol, +o746215967, ianis.siriopol@gmail.com

    Recruiting

Other trials in Romania

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 groups in NCT03237429
Study groupRoleWhat they receive
cancer patientsThe first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology
Receives: Diagnostic Test: bioimpedance spectroscopy
non-cancer patientsThe 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.

  1. 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

  2. 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.

  1. First posted2 Aug 2017
  2. Study start3 Jan 2017
  3. Primary completion1 Mar 2019 (estimated)
  4. Study completion1 Jul 2019 (estimated)

Resources

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)
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

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.

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