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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753554
• Other study ID #: 2020-281
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: February 2021
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Hyperoxia
• Oxygen Reserve Index

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul	Bakirkoy / Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation	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
Primary	Parsial oxygen pressure	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
Primary	Oxygen reserve index	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	Lactate levels	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
Secondary	Near-infrared Spectroscopy values (Left/Right)	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
Secondary	Urine & Creatinine & ALT & AST	This will be measured using blood analysis preoperatively and postoperatively. (T1: Preoperative; T8: 24 hours after operation)	24 hours
Secondary	Lung Ultrasound Scores	This will be measured by using ultrasound device preoperatively and postoperatively. (T1: Preoperative; T8: Postoperative)	24 hours
Secondary	CAM-ICU	This will be measured by examination of patient postoperatively.	24 hours