AHOE: Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Sponsor

University College Hospital Galway (Other)

Overall Status

Completed

CT.gov ID

NCT03226964

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lymphadenopathy	Device: high flow nasal oxygen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High flow nasal oxygen (Optiflow; Fisher & Paykel, Auckland, New Zealand)	Device: high flow nasal oxygen humidified high flow nasal oxygen
Active Comparator: Nasal prongs	Device: high flow nasal oxygen humidified high flow nasal oxygen

Arm

Intervention/Treatment

Experimental: High flow nasal oxygen

(Optiflow; Fisher & Paykel, Auckland, New Zealand)

Device: high flow nasal oxygen

humidified high flow nasal oxygen

Active Comparator: Nasal prongs

Device: high flow nasal oxygen

humidified high flow nasal oxygen

Outcome Measures

Primary Outcome Measures

drop in oxygen saturation during procedure [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Galway	Galway		Ireland

Sponsors and Collaborators

University College Hospital Galway

Investigators

Study Chair: David Breen, University Hospital Galway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Ahmed, Specialist Registrar in Respiratory Medicine, University College Hospital Galway

ClinicalTrials.gov Identifier:

NCT03226964

Other Study ID Numbers:

First Posted:

Jul 24, 2017

Last Update Posted:

May 2, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohammed Ahmed, Specialist Registrar in Respiratory Medicine, University College Hospital Galway

endobronchial ultrasound

high flow nasal oxygen

Additional relevant MeSH terms:

Lymphadenopathy

Study Results

No Results Posted as of May 2, 2018