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Completed

NCT Number: NCT04972500

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.

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Key information

Conditions

Perioperative Complication Hemodynamic Instability

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, 80-210, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutricia Pre-op, 400 milliliters, per os

Dietary Supplement

After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op

Primary outcomes

  1. Changes in cardiac index (CI)

    Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

    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).

  2. Changes in systemic vascular resistance index (SVRI)

    Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

    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)

  3. Changes in stroke volume (SV)

    Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

    Stroke volume will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device.

    Stroke volume will be measured in mL (milliliters).

  4. Changes in heart rate (HR)

    Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

    Heart rate will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device.

    Heart rate will be measured in 1/min (beats per minute).

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 22, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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