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NCT Number: NCT04753554

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

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.

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Key information

Conditions

Hyperoxia Cardiac Surgery Oxygen Reserve Index Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORI group

Device

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.

Conventional Group

Other

In this patient group oxygenation will be managed as usual, using blood gas analysis.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. Lactate levels

    Time frame: 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)

  2. Near-infrared Spectroscopy values (Left/Right)

    Time frame: 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)

  3. Urine & Creatinine & ALT & AST

    Time frame: 24 hours

    This will be measured using blood analysis preoperatively and postoperatively. (T1: Preoperative; T8: 24 hours after operation)

  4. Lung Ultrasound Scores

    Time frame: 24 hours

    This will be measured by using ultrasound device preoperatively and postoperatively. (T1: Preoperative; T8: Postoperative)

  5. CAM-ICU

    Time frame: 24 hours

    This will be measured by examination of patient postoperatively.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2021
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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