Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index

COLON CANCER Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02707796
• Other study ID #: 386986
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2016
• Last updated: March 11, 2016
• Start date: May 2016
• Est. completion date: November 2017

Study information

• Verified date: March 2016
• Source: Istanbul University
• Contact: cigdem akyol beyoglu
• Phone: +905052278176
• Email: akyolbeyoglu[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• COLON CANCER

Intervention

Procedure:
• Hemicolectomy

Locations

Country	Name	City	State
Turkey	Cigdem Akyol Beyoglu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Sensitivity and specificity of oxygen reserve index		During Hemicolectomy	Yes