Reducing 'bubbles' (gaseous micro-emboli) circulating in the blood system during open heart surgery

Hypobaric oxygen during cardiopulmonary bypass to reduce gaseous micro-emboli during cardiac surgery: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87042095

Enrollment

Registered

2022-06-13

Start date

2023-04-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiothoracic Surgery Surgery

Interventions

The HOME study is a single centre, single blind parallel two-group placebo-controlled RCT in which only the participants and outcome assessors will be blinded to the treatment allocation. The HCPB and

Eligibility

Sex/Gender

All

Age

40 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Age >=40 years 2. Having elective or urgent CABG or AVR (with or without an associated CABG procedure AVR±CABG) via a partial or full sternotomy using using central aortic perfusion cannulae CPB.

Exclusion criteria

Exclusion criteria: 1. History of clinical stroke within 3 months prior to randomization 2. Cardiac catheterisation within 3 days of the planned surgery 3. Cerebral and/or aortic arch arteriography or interventions within 3 days of the planned surgery 4. Active endocarditis at time of randomisation 5. Planned concomitant aortic procedure such as root replacement 6. Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization 7. Myocardial infarction in the previous 4 days 8. Participation in an interventional (drug or device) trial 9. Unable to provide written informed consent 10. Prisoner

Design outcomes

Primary

Measure	Time frame
Frequency of gaseous micro-emboli measured continually during the operation by transcranial doppler ultrasound of the middle cerebral artery	—

Secondary

Measure	Time frame
1. The markers of inflammation and oxidative stress tumour necrosis factor (TNF)-alpha, interleukins (IL)-6, IL-8, IL-10 and S100 protein levels in blood serum measured by MILLIPLEX MAP Human Neurodegenerative Disease Magnetic Bead Panel 4 - Neuroscience Multiplex Assay at baseline, 1, 4, 12 and 24 hours after the operation 2. Serious adverse events (SAEs) experienced by participants up to 30 days after the operation, including hospital readmissions in the 30 days after being discharged home from the initial heart surgery, measured by a follow-up phone call with the patient and by accessing the patient's medical records if required	—

Measure

Time frame

1. The markers of inflammation and oxidative stress tumour necrosis factor (TNF)-alpha, interleukins (IL)-6, IL-8, IL-10 and S100 protein levels in blood serum measured by MILLIPLEX MAP Human Neurodegenerative Disease Magnetic Bead Panel 4 - Neuroscience Multiplex Assay at baseline, 1, 4, 12 and 24 hours after the operation 2. Serious adverse events (SAEs) experienced by participants up to 30 days after the operation, including hospital readmissions in the 30 days after being discharged home from the initial heart surgery, measured by a follow-up phone call with the patient and by accessing the patient's medical records if required

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026