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A study comparing brain cooling method of conventional vs additional nasal cooling on aortic root surgery

Randomised prospective pilot study comparing conventional brain cooling with early additional trans-nasal cooling prior to surgery on the ascending aorta/proximal aortic arch

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11167616
Enrollment
30
Registered
2014-11-04
Start date
2014-08-04
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

Surgery on the ascending aorta/proximal aortic arch Surgery

Interventions

The patients will be randomly allocated into two groups (15 in each group with 10% drop out) using computerised simple block randomisation. Normal practice: Control Group 1

Sponsors

University Hospital of South Manchester NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients undergoing elective proximal aortic arch surgery with deep hypothermia circulatory arrest 2. Patients who have given written informed consent to take part in this study

Exclusion criteria

Exclusion criteria: 1. Patients who are not undergoing deep hypothermia circulatory arrest 2. Patients undergoing emergency operations 3. Refusal to take part in the study 4. Patients who have a history of epistaxis (nasal bleeding) requiring hospital intervention 5. Patients who have a history of nasal obstruction 6. Patients who have a history of deviated nasal septum 7. Patients who have a history of coagulopathy 8. Patients who have a history of liver dysfunction 9. Patients who have a history of renal dysfunction and also less than GFR 30

Design outcomes

Primary

MeasureTime frame
Assess if transnasal brain cooling has any effect on reducing postoperative neurological dysfunction

Secondary

MeasureTime frame
1. Assess the effect of transnasal brain cooling on: 1.1. Early mobilisation 1.2. Length of hospital stay 1.3. Requirement of sedative medications for confusion and delirium 2. Assess the effect on brain and core temperature trends when trans-nasal brain cooling is used prior to and during deep hypothermia

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026