Effects of Hyperoxia on Open Heart Surgery

NCT ID: NCT03012997

Last Updated: 2017-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Heart Valve Disease Coronary (Artery) Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Comparator: 40% oxygen

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

Group Type ACTIVE_COMPARATOR

Fraction of inspired oxygen 40%

Intervention Type OTHER

Active Comparator: 100% oxygen

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.

Group Type ACTIVE_COMPARATOR

Fraction of inspired oxygen 100%

Intervention Type OTHER

Interventions

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Fraction of inspired oxygen 40%

Intervention Type OTHER

Fraction of inspired oxygen 100%

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koşuyolu Kartal Heart Training and Research Hospital

OTHER

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Guniz M.Koksal

Professor Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guniz Koksal, Professor

Role: STUDY_DIRECTOR

Istanbul University

Locations

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Kartal Kosuyolu Training and Research Hospital

Istanbul, Marmara, Turkey (Türkiye)

Site Status RECRUITING

Kartal Kosuyolu Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Guniz Koksal, Professor

Role: CONTACT

05322067777

Facility Contacts

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emre gurcu, Specialist

Role: primary

905058917800

References

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Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21.

Reference Type BACKGROUND
PMID: 27001081 (View on PubMed)

Other Identifiers

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KK01

Identifier Type: -

Identifier Source: org_study_id

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