The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way

Preoperative fasting is considered to be refraining from taking meals for at least 6 hours and clear fluids for at least 2 hours before anesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of chyme and the occurrence of Mendelson's syndrome, and on the other hand, it is one of the causes of water and carbohydrate disturbances in patients undergoing general anesthesia. Most of them experience some degree of dehydration in the preoperative period. It is associated with a worse prognosis. Due to the negative impact of fasting on homeostasis, as well as significant changes in heart rate in participants in the previous study, we decided to measure the hemodynamic parameters during fasting. The development of impedance cardiography techniques enables the measurement of these parameters by a non-invasive method.

After obtaining the participant's written consent to participate in the study, the first measurement of body weight, blood pressure using a non-invasive method and hemodynamic parameters using a non-invasive impedance cardiography method using the Niccomo ™ device (Medizinische Messtechnik GmbH) will be performed in the evening. The subject will then be asked to refrain from food for at least 10 hours and fluid for 6 hours before the next measurement. The next morning, another measurement will be made and the participant will be randomly assigned to one of two groups: subjects in the first group will be asked to refrain from eating and drinking for another 2 hours, while subjects in the second group per os will receive 400 milliliters of PreOp® (Nutricia ™ preparation intended for preoperative dietary management in surgical patients, containing carbohydrates and electrolytes). After another two hours, the third measurement of the tested parameters will be performed. The obtained results will be subjected to statistical analysis consisting in comparing the values of hemodynamic parameters between the studied groups at appropriate measurement points.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Perioperative Complication
• Intervention / Treatment: Dietary supplement: Nutricia Pre-op, 400 milliliters, per os

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-210
      • Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiology (ASA) general condition assessment 1 or 2

Exclusion Criteria:

• Chronic kidney disease
• Circulatory failure
• Lung diseases
• Diseases of the heart valves
• History of hypoglycaemic episodes or any carbohydrate disturbance.
• Height less than 120 cm or greater than 230 cm
• Body weight less than 30 kg or greater than 155 kg.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No intervention
EXPERIMENTAL: Pre-op; Nutricia Pre-op, 400 milliliters, per os	Dietary supplement: Nutricia Pre-op, 400 milliliters, per os; After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cardiac index (CI)	Cardiac index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Cardiac index will be measured in l/min/m^2 (liters per minute per square meter).	Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Changes in systemic vascular resistance index (SVRI)	Systemic vascular resistance index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Systemic vascular resistance index will be measured in dyn*s*cm^-5*m^2 (dyne multiply by second multiply by centimeters to the power of minus 5 multiply by square meter)	Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Changes in stroke volume (SV)	Stroke volume will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Stroke volume will be measured in mL (milliliters).	Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Changes in heart rate (HR)	Heart rate will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Heart rate will be measured in 1/min (beats per minute).	Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Radoslaw Owczuk, Prof., Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2021
• Primary Completion (ACTUAL): November 4, 2021
• Study Completion (ACTUAL): November 4, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (ACTUAL): July 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PREOP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No