The Relationship Between BCM, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia

NCT03237429 | Unknown

• 1 other identifier: GTPopaUMP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Vascular Stiffness; Hypotension on Induction; Anesthesia; Reaction

Keywords

bioimpedance spectroscopy; arterial stiffness

Outcome Measures

Primary Outcomes (2)

• 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

  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

  2 years

Study Arms (2)

cancer patients

The first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology

Diagnostic Test: bioimpedance spectroscopy

non-cancer patients

The second study population will represent patients scheduled for surgery not for cancer disease

Diagnostic Test: bioimpedance spectroscopy

Interventions

bioimpedance spectroscopy DIAGNOSTIC_TEST

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.

Also known as: Carotid-femoral pulse wave velocity

cancer patients; non-cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for surgery for a new diagnosed cancer pathology

You may qualify if:

• \- patients scheduled for surgery for a new diagnosed cancer pathology

You may not qualify if:

• 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,
• sepsis,
• pregnancy,
• limb amputation.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

Regional Institute of Oncology, Iasi

Iași, Romania

RECRUITING

MeSH Terms

Interventions

Carotid-Femoral Pulse Wave Velocity

Intervention Hierarchy (Ancestors)

Pulse Wave Analysis; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dimitrie Siriopol, MD, PhD

  GRT POPA

  STUDY CHAIR

Central Study Contacts

Ianis Siriopol

CONTACT

+40746215967; ianis.siriopol@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 2, 2017
• Study Start: January 3, 2017
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

RO (1)