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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081282', 'term': 'Perfusion Index'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Arterial Pressure (ΔMAP) After Anesthesia Induction and Its Association With Plethysmographic Variability Index (PVI) and Perfusion Index (PI)', 'timeFrame': 'From baseline before induction to 5 minutes after anesthesia induction.', 'description': 'The relationship between plethysmographic variability index (PVI) and perfusion index (PI) values measured during the peri-induction period and the change in mean arterial pressure (ΔMAP) after anesthesia induction will be evaluated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Induction Hypotension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nDirect 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients aged 18-75 years with ASA physical status I-III who are scheduled to undergo elective diagnostic direct laryngoscopy under general anesthesia at the Department of Anesthesiology and Reanimation and the Department of Otorhinolaryngology of Gaziantep University Faculty of Medicine Hospital. Patients meeting the eligibility criteria and providing written informed consent will be consecutively enrolled. The study will include patients undergoing routine perioperative monitoring, and non-invasive hemodynamic parameters such as plethysmographic variability index (PVI) and perfusion index (PI) will be recorded during the peri-induction period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo elective direct laryngoscopy under general anesthesia Body mass index (BMI) between 18 and 40 kg/m² ASA physical status classification I-III Provision of written informed consent after being informed about the study\n\nExclusion Criteria:\n\n* Severe arrhythmias Advanced heart failure Severe valvular heart disease Preoperative shock or hemodynamic instability requirement for continuous vasopressor or inotropic infusion Significant peripheral vascular disease affecting peripheral circulation'}, 'identificationModule': {'nctId': 'NCT07458893', 'briefTitle': 'Prediction of Post-Induction Hypotension Using Plethysmographic Variability Index During Diagnostic Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': 'Prediction of Post-Induction Hypotension Using the Plethysmographic Variability Index in Patients Undergoing Diagnostic Laryngoscopy Under General Anesthesia', 'orgStudyIdInfo': {'id': '2026/76'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Plethysmographic Variability Index (PVI) and Perfusion Index (PI) Monitoring', 'type': 'DEVICE', 'description': 'Non-invasive monitoring of plethysmographic variability index (PVI) and perfusion index (PI) will be performed using pulse oximetry during the peri-induction period in patients undergoing diagnostic direct laryngoscopy under general anesthesia. These parameters will be recorded before anesthesia induction and during the early post-induction phase to evaluate their association with changes in mean arterial pressure and their predictive value for post-induction hypotension.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Elzem Sen, Assoc Prof', 'role': 'CONTACT', 'email': 'drelzemsen@gmail.com', 'phone': '+905327842151'}, {'name': 'Merve D Yılmaz, Dr', 'role': 'CONTACT', 'email': 'mervedeniztkmn@hotmail.com', 'phone': '+905454253505'}], 'overallOfficials': [{'name': 'Elzem Sen, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Gaziantep'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gaziantep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elzem SEN', 'investigatorAffiliation': 'University of Gaziantep'}}}}