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

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Cardiac Surgery; Hyperoxia; Oxygen Reserve Index

Treatments: Other: Conventional group; Device: ORI group

Study type: Interventional

Funder types: Other

Identifiers

NCT04753554

2020-281

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Conventional group

Active Comparator group

Description:

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

Treatment:

Device: ORI group

Other: Conventional group

ORI group

Experimental group

Description:

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

Treatment:

Device: ORI group