Lung CancerAHOENCT03226964
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
A study testing high flow nasal oxygen in people with Lung Cancer and Lymphadenopathy, run by University College Hospital Galway at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lymphadenopathy
- What is being tested?
- high flow nasal oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2016to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
- Age ≥ 18 years
- Able to breathe spontaneously throughout the procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer, Lymphadenopathy
- Being tested
- high flow nasal oxygen
- Keywords
- endobronchial ultrasound, high flow nasal oxygen
- Medical subject headings
- Lung Neoplasms, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal oxygenDevice
humidified high flow nasal oxygen
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal oxygen | Experimental | (Optiflow; Fisher \& Paykel, Auckland, New Zealand) Receives: Device: high flow nasal oxygen |
| Nasal prongs | Active comparator | Not described Receives: Device: high flow nasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
drop in oxygen saturation during procedure
the difference in oxygen saturation levels between pre-treatment assessments and the lowest saturation level achieved during treatment
Measured: through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes
Secondary outcomes (4)
change in venous CO2
Change in venous CO2 1 hour after procedure compared to pre-procedure level
Measured: 1 hour after procedure
end tidal CO2 during procedure
Measured with tip of scope at lower trachea
Measured: through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes
Patient experience measure on a visual analogue scale
Measured: up to 3 hours after procedure
endotracheal intubation during or post procedure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Oct 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed, University College Hospital Galway
- Investigators
- David Breen, Study chair, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226964
- Sponsor's protocol ID
- 1.0
- Acronym
- AHOE
- Status last verified
- Apr 2018
- First submitted
- 14 Mar 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
- ClinicalTrials.gov ID
- NCT03226964
- Acronym / sponsor ID
- AHOE / 1.0
- Conditions
- Lung Cancer, Lymphadenopathy
- Keywords
- endobronchial ultrasound, high flow nasal oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal oxygen | Experimental | Device: high flow nasal oxygen(Optiflow; Fisher \& Paykel, Auckland, New Zealand) |
| Nasal prongs | Active comparator | Device: high flow nasal oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
- Age ≥ 18 years
- Able to breathe spontaneously throughout the procedure
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal oxygenhumidified high flow nasal oxygen | Device | High flow nasal oxygen, Nasal prongs |
Primary outcome
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
4 secondary outcomes
change in venous CO2
Time frame: 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
Patient experience measure on a visual analogue scale
Time frame: up to 3 hours after procedure
endotracheal intubation during or post procedure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Breen study chair
University College Hospital Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal oxygen in people with Lung Cancer and Lymphadenopathy, run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
drop in oxygen saturation during procedure (time frame: through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.