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Trial registered on ANZCTR


Registration number
ACTRN12620000419965
Ethics application status
Approved
Date submitted
4/09/2019
Date registered
30/03/2020
Date last updated
30/03/2020
Date data sharing statement initially provided
30/03/2020
Date results information initially provided
30/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Effectiveness of Noninvasive PVI (Pleth Variability Index) Monitorization on Geriatric Treatment and Intraoperative Hemodynamics in Geriatric Surgery
Scientific title
Evaluation of the Effectiveness of Noninvasive PVI (Pleth Variability Index) Monitorization on Geriatric Treatment and Intraoperative Hemodynamics in Geriatric Surgery
Secondary ID [1] 297755 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fluid treatment management 312097 0
Condition category
Condition code
Anaesthesiology 310652 310652 0 0
Other anaesthesiology
Surgery 313272 313272 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is often not possible to determine the reserve of organ functions in geriatric patients undergoing surgical intervention. Therefore; In this age group, it is very important to apply the ideal amount of fluid and / or blood replacement during intraoperative period in order to prevent possible organ damage. The use of Perioperative Targeted Fluid Therapy Technologies helps the anesthesiologist closely monitor the patient and establish a delicate balance between benefit and risk. Plethysmatic variability index monitoring (PVI-Pleth Variability Index) is a non-invasive, automatic and continuous monitor that shows the fluid response of the patients and is one of the easily applicable and easily interpretable monitoring methods. It has been shown that intraoperative hypotension and fluid requirement can be predicted by PVI monitoring.The aim of this study was to determine the effect of Pleth Variability Index (Pleth) Index monitoring on intraoperative volume replacement in geriatric patients undergoing surgical intervention.

MATERIAL AND METHOD:
After approval of the ethics committee and written consent of the patient; 100 patients over the age of 65 (ASA class 2-3) undergoing elective surgery were included in the study. In addition to standard monitoring, PVI monitoring was performed in all patients. After randomization with closed envelope method, intraoperative fluid and blood product replacement was performed in half of the patients based on PVI data (threshold value 13%) (Group PVI); In the other half, PVI values were blinded and applied by conventional methods (Group K). Hemodynamic values, fluid and blood product amount, vasopressor requirements were recorded at 15-minute intervals and t, Mann-Whitney U or chi-square tests were evaluated. Administers the intervention by anaesthesiologists.

Intervention code [1] 313994 0
Diagnosis / Prognosis
Comparator / control treatment
control group which is used pvi monitor; however anesthesia team will be blind, another specialist will record the data. In Conventional method we replace fluids 4-7 mg/kg according to patients vital monitor parameters, heart rate and blood pressure.
Control group
Active

Outcomes
Primary outcome [1] 319499 0
arterial blood pressure changes by non invasive monitor
Timepoint [1] 319499 0
15 minute intervals during surgery
Secondary outcome [1] 368489 0
heart rate changes by non invasive monitor
Timepoint [1] 368489 0
15 minute intervals during surgery
Secondary outcome [2] 378710 0
total amount of fluid admistration from patients aneshesia records by anesthesiologist.
Timepoint [2] 378710 0
during surgery
Secondary outcome [3] 381230 0
total blood transfusion from patients aneshesia records by anesthesiologist.
Timepoint [3] 381230 0
during surgery

Eligibility
Key inclusion criteria
65 years and older,
all patients who do not meet the exclusion criteria will be included in the study.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with severe cardiac arrhythmia and peripheral arterial disease, an ejection fraction of less than 30%, mechanical ventilation and a pulmonary pathology that prevents breathing of more than 6 ml / kg and liver and kidney dysfunction will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21832 0
Turkey
State/province [1] 21832 0
istanbul

Funding & Sponsors
Funding source category [1] 302279 0
Hospital
Name [1] 302279 0
Marmara Universty Pendik Training and Education Hospital
Address [1] 302279 0
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country [1] 302279 0
Turkey
Primary sponsor type
Individual
Name
meliha orhon ergun
Address
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country
Turkey
Secondary sponsor category [1] 302154 0
Individual
Name [1] 302154 0
tumay umuroglu
Address [1] 302154 0
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country [1] 302154 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302955 0
marmara university
Ethics committee address [1] 302955 0
Basibuyuk neighborhood, Basibuyuk street. no:9, 34854 Maltese/istanbul
Ethics committee country [1] 302955 0
Turkey
Date submitted for ethics approval [1] 302955 0
Approval date [1] 302955 0
05/04/2019
Ethics approval number [1] 302955 0

Summary
Brief summary

It is often not possible to determine the reserve of organ functions in geriatric patients undergoing surgical intervention. Therefore; In this age group, it is of utmost importance to apply the ideal amount of fluid and / or blood replacement during intraoperative period in order to prevent possible organ damage. The aim of this study was to determine the effect of Pleth Variability Index (Pleth) Index monitoring on intraoperative volume replacement in geriatric patients undergoing surgical intervention.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91970 0
Dr meliha orhon ergun
Address 91970 0
Marmara Universty Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country 91970 0
Turkey
Phone 91970 0
+905413402001
Fax 91970 0
Email 91970 0
dr.meliha@gmail.com
Contact person for public queries
Name 91971 0
Dr meliha orhon ergun
Address 91971 0
Marmara Universty Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country 91971 0
Turkey
Phone 91971 0
+905413402001
Fax 91971 0
Email 91971 0
dr.meliha@gmail.com
Contact person for scientific queries
Name 91972 0
Dr meliha orhon ergun
Address 91972 0
Marmara Universty Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country 91972 0
Turkey
Phone 91972 0
+905413402001
Fax 91972 0
Email 91972 0
dr.meliha@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
The effects of standard and PVI monitoring techniques on differences in hemodynamic parameters were compared in patients undergoing general anesthesia in geriatric surgery followed by standard monitoring and non-invasive Pleth Variability Index (PVI). By detecting the change in the parameters in the early period, first the patient's need was determined and the necessary intervention could be done and intraoperative risks and complications were minimized.