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

Perfusion Index Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06407362
• Other study ID #: MAIEAH630001
• Status: Completed
• Start date: May 15, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: May 2024
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Perfusion Index
• Pleth Variability Index
• Regional Cerebral Oxygen Saturation

Intervention

Diagnostic Test:
• Cerebral Oxygen Saturation
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

Locations

Country	Name	City	State
Turkey	University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pleth Variability Index (PVI) in patients under different ventilation modes	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.	while the surgery procedure
Primary	Perfusion Index (PI) in patients under different ventilation modes	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.	while the surgery procedure
Primary	Regional Cerebral Oxygen Saturation (rSO2) in patients under different ventilation modes	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.	while the surgery procedure