The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery

July 11, 2019 updated by: Hull University Teaching Hospitals NHS Trust

The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury

The purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery reduces injury to the heart and vascular system during and after surgery. Furthermore, this study also aims to identify some of the post CABG clinical effects of HBO treatment prior to CABG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Riding Of Yorkshire
      • Hull, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Hull & East Yorkshire NHS Trust (Castle Hill Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective first time CABG
  • Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG

Exclusion Criteria:

  • Age ≤ 20 years or ≥ 85 years
  • Ejection fraction < 30%
  • Unstable angina
  • Recent myocardial infarction (< 1 month)
  • Any additional cardiac disease (e.g. arrythmia, aneurysm, valvular/septal disease, dissection or elevated pulmonary artery pressure)
  • Any end stage organ failure (e.g. renal and respiratory failure)
  • History of chronic obstructive pulmonary disease (COPD)
  • Pneumothorax
  • Pulmonary bullae
  • Convulsions
  • Current history of malignancy
  • Severe myopia or intraocular lens
  • Patients on K+(ATP) Channel Openers e.g. Nicorandil, Oral Hypoglycemics, Opioid Analgesics, Catecholamines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A
Patients in this arm were not treated with HBO prior to CABG
Experimental: B
Patients in this arm were treated with HBO prior to CABG
Drug: Hyperbaric Oxygen
100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG
Other Names:
  • Hyperbaric Oxygen Preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial Hsp72 protein
Time Frame: Intra-operative (During CABG)
Intra-operative (During CABG)
Myocardial eNOS protein
Time Frame: Intra-Operative (During CABG)
Intra-Operative (During CABG)
Serum Troponin-T
Time Frame: Peri-operative
Peri-operative
Serum soluble ICAM-1
Time Frame: Peri-operative
Peri-operative
Serum soluble PSGL-1
Time Frame: Peri-operative
Peri-operative
Serum soluble P-Selectin
Time Frame: Peri-operative
Peri-operative
Serum soluble E-Selectin
Time Frame: Peri-operative
Peri-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter
Time Frame: Peri-operative
Peri-operative
Duration of mechanical ventilation
Time Frame: Post Operative
Post Operative
Duration of endotracheal intubation
Time Frame: post operative
post operative
Length of stay in ICU
Time Frame: Post-operative
Post-operative
Blood loss
Time Frame: Post operative
Post operative
Inotrope usage
Time Frame: Post operative
Post operative
Atrial Fibrillation
Time Frame: Post operative
Post operative
Low cardiac output status
Time Frame: Post operative
Post operative
Pulmonary complications
Time Frame: Post operative
Post operative
Renal Complications
Time Frame: Post operative
Post operative
Cerebrovascular complications
Time Frame: Post operative
Post operative
Gastrointestinal complications
Time Frame: Post operative
Post operative
Wound complications
Time Frame: Post operative
Post operative
Cost of ICU stay
Time Frame: Post operative
Post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

North of England Medical & Hyperbaric Services

Investigators

  • Principal Investigator: Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS, Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R0047
  • 04/Q1104/26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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