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Completed

NCT Number: NCT06407362

Effects of Volume and Pressure-Controlled Ventilation on Cerebral SpO2, PI, and PVI Index in Septoplasty

Objective: This study was designed to evaluate the accuracy of Pleth Variability Index (PVI), Perfusion Index (PI) and Regional Oxygen Saturation (rSO2) in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia. Materials and Methods: After anaesthesia induction, ventilation was provided with volume control for 20 minutes. Heart Rate (HR), PI, PVI, Oxygen Saturation (SpO2), Non-Invasive Blood Pressure (NIBP) and rSO2 values were recorded every 5 minutes. At the 20th minute of the surgical procedure, the ventilation mode was set as the pressure-controlled mode. After switching to pressure-controlled mode, HR, PI, PVI, SpO2, NIBP and rSO2 values were recorded every 5 minutes for 20 minutes.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital

Sanliurfa, 63050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were included

Exclusion criteria

  • Those patients with any Liver and/or Kidney Failure
  • obese patients (Body Mass Index (BMI) 30 and above)
  • trauma patients
  • cancer patients
  • ASA IV patients
  • those patients with emergency surgery
  • cardiac arrhythmia
  • implanted pacemakers
  • those with a history of chronic pain

Treatment and study plan

Cerebral Oxygen Saturation

Diagnostic Test

We have designed this study to evaluate the accuracy of PVI, PI and rSO2 in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia

Other names: Pleth Variability Index, Perfusion Index

Primary outcomes

  1. Pleth Variability Index (PVI) in patients under different ventilation modes

    Time frame: while the surgery procedure

    The objective of this study was to demonstrate the percentage difference in the Pleth Variability Index (PVI) between the two ventilation modes in patients undergoing septorhinoplasty.

  2. Perfusion Index (PI) in patients under different ventilation modes

    Time frame: while the surgery procedure

    The objective of this study was to demonstrate the percentage difference in the Perfusion Index (PI) between the two ventilation modes in patients undergoing septorhinoplasty.

  3. Regional Cerebral Oxygen Saturation (rSO2) in patients under different ventilation modes

    Time frame: while the surgery procedure

    The objective of this study was to demonstrate the percentage difference in the Regional Cerebral Oxygen Saturation (rSO2) between the two ventilation modes in patients undergoing septorhinoplasty.

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Official study title

Evaluation of the Effects of Volume-Controlled and Pressure-Controlled Ventilation on Cerebral Oxygen Saturation, Perfusion Index, and Pleth Variability Index in Septoplasty Surgical Cases: an Observational Prospective Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 9, 2024
Registry last updated
May 9, 2024

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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