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

Primary Purpose

Hyperoxia, Oxygen Reserve Index, Cardiac Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ORI group
Conventional group
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hyperoxia focused on measuring hyperoxia, ORI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional group

ORI group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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)
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)
Urine & Creatinine & ALT & AST
This will be measured using blood analysis preoperatively and postoperatively. (T1: Preoperative; T8: 24 hours after operation)
Lung Ultrasound Scores
This will be measured by using ultrasound device preoperatively and postoperatively. (T1: Preoperative; T8: Postoperative)
CAM-ICU
This will be measured by examination of patient postoperatively.

Full Information

First Posted
February 11, 2021
Last Updated
February 11, 2021
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04753554
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia, Oxygen Reserve Index, Cardiac Surgery
Keywords
hyperoxia, ORI

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
The patient group that whose oxygenation will be managed by blood gas analysis.
Arm Title
ORI group
Arm Type
Experimental
Arm Description
The patient group that whose oxygenation will be managed by ORI values
Intervention Type
Device
Intervention Name(s)
ORI group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional group
Intervention Description
In this patient group oxygenation will be managed as usual, using blood gas analysis.
Primary Outcome Measure Information:
Title
Oxygen saturation
Description
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)
Time Frame
24 hours
Title
Parsial oxygen pressure
Description
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)
Time Frame
24 hours
Title
Oxygen reserve index
Description
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)
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Lactate levels
Description
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)
Time Frame
24 hours
Title
Near-infrared Spectroscopy values (Left/Right)
Description
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)
Time Frame
24 hours
Title
Urine & Creatinine & ALT & AST
Description
This will be measured using blood analysis preoperatively and postoperatively. (T1: Preoperative; T8: 24 hours after operation)
Time Frame
24 hours
Title
Lung Ultrasound Scores
Description
This will be measured by using ultrasound device preoperatively and postoperatively. (T1: Preoperative; T8: Postoperative)
Time Frame
24 hours
Title
CAM-ICU
Description
This will be measured by examination of patient postoperatively.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy / Istanbul
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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