Back to resultsCorrelation Between Partial Oxygen Pressure and Oxygen Reserve Index
Primary Purpose
COLON CANCER
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hemicolectomy
Sponsored by
About this trial
This is an interventional screening trial for COLON CANCER focused on measuring oxygen reserve index, partial oxygen pressure, hemicolectomy
Eligibility Criteria
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
Sites / Locations
- Cigdem Akyol Beyoglu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemicolectomy
Arm Description
Oxygen reserve index and partial oxygen pressure will be noted for patients undergoing hemicolectomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Sensitivity and specificity of oxygen reserve index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02707796
Brief Title
Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COLON CANCER
Keywords
oxygen reserve index, partial oxygen pressure, hemicolectomy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hemicolectomy
Arm Type
Experimental
Arm Description
Oxygen reserve index and partial oxygen pressure will be noted for patients undergoing hemicolectomy
Intervention Type
Procedure
Intervention Name(s)
Hemicolectomy
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Sensitivity and specificity of oxygen reserve index
Time Frame
During Hemicolectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cigdem akyol beyoglu
Phone
+905052278176
Email
akyolbeyoglu@gmail.com
Facility Information:
Facility Name
Cigdem Akyol Beyoglu
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cigdem akyol beyoglu
Phone
+905052278176
Email
akyolbeyoglu@gmail.com
12. IPD Sharing Statement
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Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index
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