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

NCT06407362 | Completed

• 1 other identifier: MAIEAH630001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilation Mode; Pleth Variability Index; Perfusion Index; Regional Cerebral Oxygen Saturation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Patients who had undergone septoplasty

Diagnostic Test: Cerebral Oxygen Saturation

Interventions

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

Also known as: Pleth Variability Index, Perfusion Index

Patients who had undergone septoplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were undergoing septoplasty surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

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

Sanliurfa, 63050, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: May 15, 2021
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

TU (1)