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Clinical Trials/NCT02707796
NCT02707796UnknownNot Applicable

Evaluation of the Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index, and Sensitivity and Specificity of Oxygen Reserve Index in Patients Undergoing Hemicolectomy

Istanbul University1 site in 1 country240 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
240
Locations
1
Primary Endpoint
Evaluation of the correlation between partial oxygen pressure in arterial blood sample and oxygen reserve index calculated by pulse co-oximetry, and sensitivity and specificity of oxygen reserve index in patients undergoing hemicolectomy

Study Overview

Brief Summary

Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new technological development in medical science. Our aim in this study is to identify the correlation between arterial oxygen pressure (PaO2) and ORI, and to identify the specificity and sensitivity of ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery patients.

Detailed Description

Patients aged between 20-55 years old,American Society of Anesthesiologists physical status 1-2 who will have hemicolectomy will be included to the study. If hemodynamic instability or a sudden decrease in oxygen saturation by pulse oximetry (SpO2) occurs, arterial blood gas analysis will be taken from the patient and ORI, SpO2, PaO2, and arterial oxygen saturation (SaO2) will be recorded. The primer endpoint of the study is to identify the correlation between PaO2 and ORI, seconder end-point is to identify the specificity and sensitivity of ORI as a detector of PaO2. Pearson test for correlation, regression analysis for sensitivity and specificity will be performed. The study will include 240 patients according to power analysis

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients aged between 20-55 years old
  • •American Society of Anesthesiologists physical status I-II
  • •Patients undergoing hemicolectomy

Exclusion Criteria

  • •Chronic obstructive and restrictive pulmonary disease
  • •Diabetes Mellitus
  • •Ischemic heart disease
  • •Peripheric artery disease.
  • •Operations longer than 200 minutes, requirement transfusion of more than 1 U erythrocyte suspension, and requirement of vasopressor or inotrope infusion will be excluded from the study

Arms & Interventions

Hemicolectomy

Experimental

Oxygen reserve index and partial oxygen pressure will be noted for patients undergoing hemicolectomy

Intervention: Hemicolectomy (Procedure)

Outcomes

Primary Outcomes

Evaluation of the correlation between partial oxygen pressure in arterial blood sample and oxygen reserve index calculated by pulse co-oximetry, and sensitivity and specificity of oxygen reserve index in patients undergoing hemicolectomy

Time Frame: oxygen reserve index and peripheric oxygen saturation will be recorded before and after induction of anesthesia, and every 5 minutes and arterial partial oxygen pressure in every 30 minutes during hemicolectomy.

Secondary Outcomes

  • Sensitivity and specificity of oxygen reserve index(During Hemicolectomy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Cigdem Akyol Beyoğlu

MD

Istanbul University

Study Sites (1)

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