Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Lung Cancer Clinical Trial

— AHOE  

Official title:

Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226964
• Other study ID #: 1.0
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2018
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lymphadenopathy

Intervention

Device:
• high flow nasal oxygen
humidified high flow nasal oxygen

Locations

Country	Name	City	State
Ireland	University Hospital Galway	Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in venous CO2	Change in venous CO2 1 hour after procedure compared to pre-procedure level	1 hour after procedure
Secondary	end tidal CO2 during procedure	Measured with tip of scope at lower trachea	through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes
Secondary	Patient experience measure on a visual analogue scale		up to 3 hours after procedure
Secondary	endotracheal intubation during or post procedure		24 hours