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

Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048162
• Other study ID #: OMU KAEK 2016/390
• Status: Completed
• Phase: N/A
• First received: February 4, 2017
• Last updated: May 15, 2017
• Start date: February 13, 2017
• Est. completion date: May 15, 2017

Study information

• Verified date: May 2017
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Perfusion

Intervention

Drug:
• sodium chloride
500 ml of 0.9% isotonic sodium chloride
• Hydroxyethylstarch
500 ml of 6% Hydroxyethylstarch
• Ringer-Lactate Infusion Solution Bag
500 ml of Ringer-Lactate Infusion Solution Bag

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion index	The perfusion of the tissues	six months
Secondary	Heart rate	Heart rate	six months
Secondary	Blood pressure	Non-invasive lood pressure	six months
Secondary	Oxygen saturation	Blood oxygen saturation using pulse oximeter	six months
Secondary	Pulse variability index	The intravenous fluid requirement of the tissues	six months