Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index

Not Applicable

• Conditions: COLON CANCER
• Interventions: Procedure: Hemicolectomy

• Registration Number: NCT02707796
• Lead Sponsor: Istanbul University

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 Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Study First Posted: 2016-03-14
• Last Update Posted: 2016-03-14
• Study Start: 2016-05
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemicolectomy	Hemicolectomy	Oxygen reserve index and partial oxygen pressure will be noted for patients undergoing hemicolectomy

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Sensitivity and specificity of oxygen reserve index	During Hemicolectomy

Trial Locations

Locations (1)

Cigdem Akyol Beyoglu; 🇹🇷 Istanbul, Turkey