Can Hyperoxia be Prevented With Noninvasive Monitoring in On-pump Cardiac Surgery?

February 11, 2021 updated by: Ipek Bostancı, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
In our study, we aimed to observe the usability of non-invasive monitoring methods in oxygenation management, using non-invasive monitoring techniques, preventing hyperoxia and avoiding oxidative damage-related complications in patients undergoing on-pump cardiac surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In on-pump cardiac surgery; The risk of organ perfusion disorders is high due to the heart-lung pump process they involve. It is essential to avoid hypoxia in such patient groups in order to prevent perfusion disorders. While preventing hypoxia, hyperoxia processes can be observed frequently in patients. In order to avoid complications related to hyperoxia and oxidative damage, oxygenation management should be followed closely. Today, non-invasive monitoring methods are being used in this field. In our study, we aimed to observe the usability of this method in oxygenation management and avoidance of hyperoxia by performing oxygenation management over ORI (oxygene reserve index) value using the Masimo Root + Radical 7 Rainbow SET device with SPHB finger probe.

30 patients will bi included in our study; and they will be divided into two groups: In one group oxygenation management will be performed by conventional method, such as blood gas analysis. In other group ORI values will be used to manage oxygenation. Lung ultrasound will be performed in both groups to see if there will be any sign for atelectasis, preoperatively and postoperatively.

Kidney and liver functions will also be investigated before and after surgery. For cognitive disfunction evaluation; CAM-ICU scores will be recorded in both groups at 24 hours after the operation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakirkoy / Istanbul
      • Istanbul, Bakirkoy / Istanbul, Turkey, 34147
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 18 - 75
  • Patients undergoing on-pump cardiac surgery

Exclusion Criteria:

  • Patients with advanced CHF (EF <40%)
  • Patients with advanced COPD (FEV1 <60%)
  • Patients with a history of CVD
  • Patients with advanced carotid lesions (> 50-70% of stenosis)
  • Patients with renal failure
  • Patients with liver failure
  • Patients with cardiac arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Conventional group
The patient group that whose oxygenation will be managed by blood gas analysis.
Device: ORI group
The patient group whose oxygenation will be managed by ORI values. Hyperoxia or hypoxia will be prevented by using also blood gas analysis in critically ill patients.
Other: Conventional group
In this patient group oxygenation will be managed as usual, using blood gas analysis.
EXPERIMENTAL: ORI group
The patient group that whose oxygenation will be managed by ORI values
Device: ORI group
The patient group whose oxygenation will be managed by ORI values. Hyperoxia or hypoxia will be prevented by using also blood gas analysis in critically ill patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: 24 hours
This will be measured preoperatively; routinely 4 times perioperatively, if there is any intervention after the intervention; and 3 times postoperatively. Reported as % (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation; T6: 2 hours after operation; T7: After extubation; T8: 24 hours after operation)
24 hours
Parsial oxygen pressure
Time Frame: 24 hours
This will be measured preoperatively by blood gas analysis; routinely 4 times perioperatively, if there is any intervention after the intervention; and 3 times postoperatively. Reported as mmHg. (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation; T6: 2 hours after operation; T7: After extubation; T8: 24 hours after operation)
24 hours
Oxygen reserve index
Time Frame: 6 hours
This will be measured only in ORI group patients using Masimo device preoperatively; routinely 4 times perioperatively and if there is any intervention after the intervention. (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation)
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lactate levels
Time Frame: 24 hours
This will be measured by blood gas analysis; preoperatively; routinely 4 times perioperatively, if there is any intervention after the intervention; and 3 times postoperatively. (T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation; T6: 2 hours after operation; T7: After extubation; T8: 24 hours after operation)
24 hours
Near-infrared Spectroscopy values (Left/Right)
Time Frame: 24 hours
This will be measured using Masimo device; preoperatively; routinely 4 times perioperatively, if there is any intervention after the intervention; and 1 time postoperatively. T1: Preoperative, T2: after intubation, T3: aortic cross clemp o, T4: aortic cross clemp off, T5: After decanullation; T8: 24 hours after operation)
24 hours
Urine & Creatinine & ALT & AST
Time Frame: 24 hours
This will be measured using blood analysis preoperatively and postoperatively. (T1: Preoperative; T8: 24 hours after operation)
24 hours
Lung Ultrasound Scores
Time Frame: 24 hours
This will be measured by using ultrasound device preoperatively and postoperatively. (T1: Preoperative; T8: Postoperative)
24 hours
CAM-ICU
Time Frame: 24 hours
This will be measured by examination of patient postoperatively.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on ORI group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings