Effects of Hyperoxia on Open Heart Surgery

Istanbul University

Status: Unknown

Conditions: Coronary (Artery) Disease; Heart Valve Disease

Treatments: Other: Fraction of inspired oxygen 100%; Other: Fraction of inspired oxygen 40%

Study type: Interventional

Funder types: Other

Identifiers

NCT03012997

KK01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Active Comparator: 40% oxygen

Active Comparator group

Description:

Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.

Treatment:

Other: Fraction of inspired oxygen 40%

Active Comparator: 100% oxygen

Active Comparator group

Description:

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.

Treatment:

Other: Fraction of inspired oxygen 100%