Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:15 AM
Study NCT ID:
NCT07458893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Post-Induction Hypotension Using Plethysmographic Variability Index During Diagnostic Laryngoscopy
Sponsor:
University of Gaziantep
Organization:
Study Overview
Official Title:
Prediction of Post-Induction Hypotension Using the Plethysmographic Variability Index in Patients Undergoing Diagnostic Laryngoscopy Under General Anesthesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective observational study aims to evaluate whether non-invasive hemodynamic parameters, including the plethysmographic variability index (PVI) and perfusion index (PI), can predict post-induction hypotension in patients undergoing diagnostic direct laryngoscopy under general anesthesia. Patients aged 18-75 years with ASA physical status I-III scheduled for elective direct laryngoscopy will be included. PVI and PI values will be recorded before anesthesia induction and in the early post-induction period. The relationship between these indices and the decrease in mean arterial pressure after induction will be analyzed to determine their predictive value for hypotension.
Detailed Description:
Post-induction hypotension is a common hemodynamic complication during the early phase of general anesthesia and may lead to adverse perioperative outcomes, particularly in patients with limited physiological reserve. Early identification of patients at risk for hypotension may allow clinicians to implement preventive strategies and optimize perioperative hemodynamic management. Recently, non-invasive perfusion-related parameters derived from pulse oximetry have gained attention as potential indicators of intravascular volume status and cardiovascular responsiveness.
The plethysmographic variability index (PVI) is a dynamic parameter reflecting respiratory variations in the perfusion index and is considered a non-invasive surrogate marker of fluid responsiveness. The perfusion index (PI), which represents the ratio of pulsatile to non-pulsatile blood flow in peripheral tissues, provides information about peripheral perfusion and vascular tone. These indices are continuously and non-invasively obtained using pulse oximetry and may offer clinically useful information regarding hemodynamic status during anesthesia induction.
Direct laryngoscopy performed under general anesthesia may be associated with significant hemodynamic fluctuations during both the induction phase and airway manipulation. Identifying reliable non-invasive predictors of blood pressure reduction during this period may improve intraoperative monitoring and facilitate early intervention.
The plethysmographic variability index (PVI) is a dynamic parameter reflecting respiratory variations in the perfusion index and is considered a non-invasive surrogate marker of fluid responsiveness. The perfusion index (PI), which represents the ratio of pulsatile to non-pulsatile blood flow in peripheral tissues, provides information about peripheral perfusion and vascular tone. These indices are continuously and non-invasively obtained using pulse oximetry and may offer clinically useful information regarding hemodynamic status during anesthesia induction.
Direct laryngoscopy performed under general anesthesia may be associated with significant hemodynamic fluctuations during both the induction phase and airway manipulation. Identifying reliable non-invasive predictors of blood pressure reduction during this period may improve intraoperative monitoring and facilitate early intervention.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: