Coronary (Artery) Disease, Heart Valve Disease
Conditions
Brief summary
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit. Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.
Interventions
OTHERFraction of inspired oxygen 100%
Sponsors
Koşuyolu Kartal Heart Training and Research Hospital
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA II-III * Patients with EF higher than 50%. * patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)
Exclusion criteria
* patients with Diabetes Mellitus * patients with COPD * Patients with Cerebral Vascular Disease * Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and hypercarbia (PaCO2 higher than 45 mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between before and after cardiopulmonary bypass | 72 hours | As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial pressure of carbondioxide(mm Hg) | 72 hours | ,Partial pressure of carbondioxide(mm Hg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| lactate (mmol/l) | 72 hours | lactate (mmol/l) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| ph values | 72 hours | ph values in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| Partial pressure of oxygen(mmHg), | 72 hours | Partial pressure of oxygen(mmHg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| diastolic arterial pressure (mmHg) | 72 hours | diastolic arterial pressure (mmHg) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| Oxygen saturation (%) | 72 hours | Oxygen saturation (%) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| heart rate (beat/min) | 72 hours | heart rate (beat/min) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
| systolic arterial pressure (mmHg), | 72 hours | systolic arterial pressure (mmHg), levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactGuniz Koksal, Professor
Outcome results
None listed