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Clinical Trials/NCT04753554
NCT04753554
Completed
Not Applicable

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

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 site in 1 country30 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperoxia
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Enrollment
30
Locations
1
Primary Endpoint
Oxygen reserve index
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ipek Bostancı

Specialist, MD

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

Outcomes

Primary Outcomes

Oxygen reserve index

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Lactate levels(24 hours)
  • Urine & Creatinine & ALT & AST(24 hours)
  • CAM-ICU(24 hours)
  • Near-infrared Spectroscopy values (Left/Right)(24 hours)
  • Lung Ultrasound Scores(24 hours)

Study Sites (1)

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