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

Not Applicable

Completed

• Conditions: Hyperoxia; Oxygen Reserve Index; Cardiac Surgery
• Interventions: Device: ORI group; Other: Conventional group

• Registration Number: NCT04753554
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Study First Posted: 2021-02-15
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORI group	ORI group	The patient group that whose oxygenation will be managed by ORI values
Conventional group	ORI group	The patient group that whose oxygenation will be managed by blood gas analysis.
Conventional group	Conventional group	The patient group that whose oxygenation will be managed by blood gas analysis.

Primary Outcome Measures

Name	Time	Method
Oxygen reserve index	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)
Parsial oxygen pressure	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)
Oxygen saturation	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)

Secondary Outcome Measures

Name	Time	Method
Lactate levels	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)
Urine & Creatinine & ALT & AST	24 hours	This will be measured using blood analysis preoperatively and postoperatively. (T1: Preoperative; T8: 24 hours after operation)
CAM-ICU	24 hours	This will be measured by examination of patient postoperatively.
Near-infrared Spectroscopy values (Left/Right)	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)
Lung Ultrasound Scores	24 hours	This will be measured by using ultrasound device preoperatively and postoperatively. (T1: Preoperative; T8: Postoperative)

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Istanbul, Bakirkoy / Istanbul, Turkey