The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index

The Evaluation of the Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index

This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

Study Overview

• Status: Completed
• Conditions: Perfusion
• Intervention / Treatment: Drug: sodium chloride; Drug: Hydroxyethylstarch; Drug: Ringer-Lactate Infusion Solution Bag

Detailed Description

Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and pulse variability index are the recent parameters to evaluate the tissue microcirculatory condition. This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be taken to recovery room in the operating theatre and wait for 15 minutes to balance the skin temperature of the patients to the environment. Patients will be randomly divided into three groups using closed envelope technique as Group L (received 500 ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6% hydroxyethylstarch). Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60200
    • Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• having a fasting period of 8 hours
• quit smoking for 8 hours before the procedure

Exclusion Criteria:

• not to participate in the study
• presence of peripheral vascular disease
• a history of upper extremity surgery
• presence of any kind of psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sodium chloride; 0.9% isotonic sodium chloride, 500 ml, one package in 30 minutes	Drug: sodium chloride; 500 ml of 0.9% isotonic sodium chloride
Active Comparator: Hydroxyethylstarch; 6% hydroxyethylstarch, 500 ml, one package in 30 minutes	Drug: Hydroxyethylstarch; 500 ml of 6% Hydroxyethylstarch
Active Comparator: Ringer-Lactate Infusion Solution Bag; Ringer's lactate, 500 ml, one package in 30 minutes	Drug: Ringer-Lactate Infusion Solution Bag; 500 ml of Ringer-Lactate Infusion Solution Bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion index	The perfusion of the tissues	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate	six months
Blood pressure	Non-invasive lood pressure	six months
Oxygen saturation	Blood oxygen saturation using pulse oximeter	six months
Pulse variability index	The intravenous fluid requirement of the tissues	six months

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Investigators: Principal Investigator: Seval Ekerer, Dr, Gaziosmanpasa University; Principal Investigator: Mustafa Suren, Dr, Gaziosmanpasa University; Principal Investigator: Serkan Karaman, Dr, Gaziosmanpasa University; Principal Investigator: Tugba Karaman, Dr, Gaziosmanpasa University; Principal Investigator: Hakan Tapar, Dr, Gaziosmanpasa University; Principal Investigator: Aynur Sahin, Dr, Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: February 4, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OMU KAEK 2016/390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No