Clinical trial NCT04753554: Can Hyperoxia be Prevented With Noninvasive Monitoring in On-pump Cardiac Surgery?
Official title: Can Hyperoxia be Prevented With Noninvasive Monitoring in On-pump Cardiac Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperoxia
Oxygen Reserve Index
Cardiac Surgery
Keywords: hyperoxia
ORI
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygen saturation
timeFrame: 24 hours
measure: Parsial oxygen pressure
timeFrame: 24 hours
measure: Oxygen reserve index
timeFrame: 6 hours
Secondary outcomes:
measure: Lactate levels
timeFrame: 24 hours
measure: Near-infrared Spectroscopy values (Left/Right)
timeFrame: 24 hours
measure: Urine & Creatinine & ALT & AST
timeFrame: 24 hours
measure: Lung Ultrasound Scores
timeFrame: 24 hours
measure: CAM-ICU
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
state: Bakirkoy / Istanbul
Study officials:
References: