Back to resultsAssessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy (AHOE)
Primary Purpose
Lung Cancer, Lymphadenopathy
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
high flow nasal oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring endobronchial ultrasound, high flow nasal oxygen
Eligibility Criteria
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
Sites / Locations
- University Hospital Galway
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High flow nasal oxygen
Nasal prongs
Arm Description
(Optiflow; Fisher & Paykel, Auckland, New Zealand)
Outcomes
Primary Outcome Measures
drop in oxygen saturation during procedure
the difference in oxygen saturation levels between pre-treatment assessments and the lowest saturation level achieved during treatment
Secondary Outcome Measures
change in venous CO2
Change in venous CO2 1 hour after procedure compared to pre-procedure level
end tidal CO2 during procedure
Measured with tip of scope at lower trachea
Patient experience measure on a visual analogue scale
endotracheal intubation during or post procedure
Full Information
NCT ID
NCT03226964
First Posted
March 14, 2017
Last Updated
April 30, 2018
Sponsor
University College Hospital Galway
1. Study Identification
Unique Protocol Identification Number
NCT03226964
Brief Title
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
Acronym
AHOE
Official Title
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lymphadenopathy
Keywords
endobronchial ultrasound, high flow nasal oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal oxygen
Arm Type
Experimental
Arm Description
(Optiflow; Fisher & Paykel, Auckland, New Zealand)
Arm Title
Nasal prongs
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
high flow nasal oxygen
Intervention Description
humidified high flow nasal oxygen
Primary Outcome Measure Information:
Title
drop in oxygen saturation during procedure
Description
the difference in oxygen saturation levels between pre-treatment assessments and the lowest saturation level achieved during treatment
Time Frame
through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes
Secondary Outcome Measure Information:
Title
change in venous CO2
Description
Change in venous CO2 1 hour after procedure compared to pre-procedure level
Time Frame
1 hour after procedure
Title
end tidal CO2 during procedure
Description
Measured with tip of scope at lower trachea
Time Frame
through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes
Title
Patient experience measure on a visual analogue scale
Time Frame
up to 3 hours after procedure
Title
endotracheal intubation during or post procedure
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Breen
Organizational Affiliation
University Hospital Galway
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
We'll reach out to this number within 24 hrs