NCT02707796

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

March 2, 2016

Last Update Submit

March 11, 2016

Conditions

Keywords

oxygen reserve index, partial oxygen pressure, hemicolectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sensitivity and specificity of oxygen reserve index

    During Hemicolectomy

Study Arms (1)

Hemicolectomy

EXPERIMENTAL

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

Procedure: Hemicolectomy

Interventions

HemicolectomyPROCEDURE
Hemicolectomy

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigdem Akyol Beyoglu

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

cigdem akyol beyoglu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 14, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations