Effects of Hyperoxia on Open Heart Surgery

Not Applicable

• Conditions: Coronary (Artery) Disease; Heart Valve Disease
• Interventions: Other: Fraction of inspired oxygen 40%; Other: Fraction of inspired oxygen 100%

• Registration Number: NCT03012997
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-09
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-05
• Last Update Submitted: 2017-01-05
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: 40% oxygen	Fraction of inspired oxygen 40%	Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.
Active Comparator: 100% oxygen	Fraction of inspired oxygen 100%	Patients in this group will be ventilated with fraction of inspired oxygen during 100% induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Kartal Kosuyolu Training and Research Hospital; 🇹🇷 Istanbul, Turkey