Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index

NCT ID: NCT02707796

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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

Conditions

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COLON CANCER

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Hemicolectomy

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

Group Type EXPERIMENTAL

Hemicolectomy

Intervention Type PROCEDURE

Interventions

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Hemicolectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Dr Cigdem Akyol Beyoğlu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cigdem Akyol Beyoglu

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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cigdem akyol beyoglu

Role: CONTACT

+905052278176

Facility Contacts

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cigdem akyol beyoglu

Role: primary

+905052278176

Other Identifiers

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386986

Identifier Type: -

Identifier Source: org_study_id

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