Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
AHOE
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 2, 2018
April 1, 2018
1.5 years
March 14, 2017
April 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
drop in oxygen saturation during procedure
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 Outcomes (4)
change in venous CO2
1 hour after procedure
end tidal CO2 during procedure
through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes
Patient experience measure on a visual analogue scale
up to 3 hours after procedure
endotracheal intubation during or post procedure
24 hours
Study Arms (2)
High flow nasal oxygen
EXPERIMENTAL(Optiflow; Fisher \& Paykel, Auckland, New Zealand)
Nasal prongs
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
- Age ≥ 18 years
- Able to breathe spontaneously throughout the procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Galway
Galway, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Breen
University Hospital Galway
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist Registrar in Respiratory Medicine
Study Record Dates
First Submitted
March 14, 2017
First Posted
July 24, 2017
Study Start
October 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
May 2, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share