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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperoxia Oxygen Reserve Index Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional group

The patient group that whose oxygenation will be managed by blood gas analysis.

Group Type ACTIVE_COMPARATOR

ORI group

Intervention Type DEVICE

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.

Conventional group

Intervention Type OTHER

In this patient group oxygenation will be managed as usual, using blood gas analysis.

ORI group

The patient group that whose oxygenation will be managed by ORI values

Group Type EXPERIMENTAL

ORI group

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Conventional group

In this patient group oxygenation will be managed as usual, using blood gas analysis.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No