COLON CANCERNCT02707796
Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index
A study testing Hemicolectomy in people with COLON CANCER, run by Istanbul University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- COLON CANCER
- What is being tested?
- Hemicolectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 20-55 years old
- American Society of Anesthesiologists physical status I-II
- Patients undergoing hemicolectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cigdem Akyol Beyoglu
Istanbul, 34000
cigdem akyol beyoglu, +905052278176, akyolbeyoglu@gmail.com
About this study
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
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.
Read the 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
- Conditions
- COLON CANCER
- Being tested
- Hemicolectomy
- Keywords
- oxygen reserve index, partial oxygen pressure, hemicolectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemicolectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hemicolectomy | Experimental | Oxygen reserve index and partial oxygen pressure will be noted for patients undergoing hemicolectomy Receives: Procedure: Hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During Hemicolectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COLON CANCERStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Cigdem Akyol Beyoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707796
- Sponsor's protocol ID
- 386986
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02707796
- Acronym / sponsor ID
- 386986
- Conditions
- COLON CANCER
- Keywords
- oxygen reserve index, partial oxygen pressure, hemicolectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemicolectomy | Experimental | Procedure: HemicolectomyOxygen reserve index and partial oxygen pressure will be noted for patients undergoing hemicolectomy |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged between 20-55 years old
- American Society of Anesthesiologists physical status I-II
- Patients undergoing hemicolectomy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemicolectomy | Procedure or surgery | Hemicolectomy |
Primary outcome
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.
1 secondary outcome
Sensitivity and specificity of oxygen reserve index
Time frame: During Hemicolectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemicolectomy in people with COLON CANCER, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cigdem akyol beyoglu (+905052278176, akyolbeyoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.