- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226964
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy (AHOE)
This study is a prospective randomised trial where a computer will randomly allocate
patients to one of two possible methods of delivering oxygen during the procedure of
bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in
delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-
bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.
HFNC uses humidified higher gas flow rates than conventional low flow systems such as
nasal prongs which are limited by the respiratory rate and effort.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Galway, Ireland
- University Hospital Galway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
- Age ≥ 18 years
- Able to breathe spontaneously throughout the procedure
Exclusion Criteria:
- Respiratory or cardiac failure
- Recent myocardial infarction < 6 weeks ago
- On long term oxygen therapy, those with tracheostomy and/ or non-invasive or invasive mechanical ventilation
- Nasal and/ or nasopharyngeal disease
- Inability to give informed consent
- Dementia
- Hepatic or end stage renal disease
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High flow nasal oxygen
(Optiflow; Fisher & Paykel, Auckland, New Zealand)
|
humidified high flow nasal oxygen
|
Active Comparator: Nasal prongs
|
humidified high flow nasal oxygen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
drop in oxygen saturation during procedure
Time Frame: through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes
|
the difference in oxygen saturation levels between pre-treatment assessments and the lowest saturation level achieved during treatment
|
through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in venous CO2
Time Frame: 1 hour after procedure
|
Change in venous CO2 1 hour after procedure compared to pre-procedure level
|
1 hour after procedure
|
end tidal CO2 during procedure
Time Frame: through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes
|
Measured with tip of scope at lower trachea
|
through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes
|
Patient experience measure on a visual analogue scale
Time Frame: up to 3 hours after procedure
|
up to 3 hours after procedure
|
|
endotracheal intubation during or post procedure
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Investigators
- Study Chair: David Breen, University Hospital Galway
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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