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To Assess Ear Blood Flow During Dialysis

Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02545920
Enrollment
10
Registered
2015-09-10
Start date
2015-09-30
Completion date
2021-08-30
Last updated
2020-11-04

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

Conditions

Kidney Failure

Keywords

haemodialysis, hypotension

Brief summary

This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.

Detailed description

10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal. Patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.

Interventions

OTHERno intervention

observational study

Sponsors

University College, London
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients age 18 years and older up to 80 years * Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration. * Able to provide written informed consent obtained

Exclusion criteria

* Patients unable to provide written informed consent * Patients using hearing aids * Patients who have had previous middle ear surgery * Patients not fulfilling inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
change in ear blood flowday 1 dialysis sessionpercentage change in ear blood flow compared to initial ear blood flow

Secondary

MeasureTime frameDescription
change in blood pressureday 1 dialysis sessionchange in blood pressure in mmHg compared to starting blood pressure
change in haematocrit volume statusday 1 dialysis sessionpercentage change in haematocrit
record of hypotensive episodes during dialysisday 1 dialysis sessionrecord of nursing interventions including reduction in ultrafiltration volume, administration of intravenous fluids. Use of distress thermometer visual analogue scale to record patient symptoms

Countries

United Kingdom

Contacts

Primary Contactvashist deelchand
vashist.deelchand@nhs.net02077940500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026