Cardiovascular DiseasesNCT03619148
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
A study testing High-Flow Humidified Nasal Oxygen in people with Cardiovascular Diseases, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Optiflow (high flow humified nasal oxygen) is used in several settings frequently (ICU, during elective general anaesthesia- commonly here on the TOE list, in certain ENT patients, and more commonly now in obese or obstetric patients for preoxygenation). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- High-Flow Humidified Nasal Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2018to 26 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers (staff) - from the anaesthetics department and willing to be exposed to HFNO
- Patients listed for all those undergoing elective TOE requiring sedation and use of HFNO
- present at Torbay Hospital
- Greater than 18 years of age. No upper age limit
- Able to give informed consent
Who cannot join
- patient refusal
- lack of capacity
- poor understanding of English
- respiratory tract symptoms
- blocked nostrils
- current or recurrent epistaxis
Show all 9Show fewer
- nasal steroid treatment
- Ages <18 years
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence and Severity of Upper Respiratory Tract Symptoms Associated With The Use of High-Flow Humidified Nasal Oxygen (HFNO)
Optiflow (high flow humified nasal oxygen) is used in several settings frequently (ICU, during elective general anaesthesia- commonly here on the TOE list, in certain ENT patients, and more commonly now in obese or obstetric patients for preoxygenation). To the investigators knowledge no one has quantified the common complications associated with it (based on a literature search in November 2017 using PubMed and Google; using the search terms "high flow nasal oxygen" combined with "complications", "side effects", "nasal dryness" and "epistaxis"). The investigators were unable to find any existing research that examined the days following HFNO use and specifically looked for minor side effects) The investigators have had anecdotal feedback from patients that they tend to experience respiratory symptoms post HFNO.
THe investigators would like to determine how often this occurs and how long it lasts for which would be pertinent to consent, and informing patients prior to the procedure, and also serve to improve the literature on this up and coming technique.
Read the detailed description
The study aims to evaluate what is the frequency and severity of respiratory tract symptoms following the use of high flow nasal humidified oxygen? Participants will be from 2 sub groups:
- Patients already undergoing TOE (as this is the most common and consistent group who have optiflow- about 4-5 patients per week)
- Volunteers (staff) who would agree to experience the optiflow whilst awake for the same period as those undergoing TOE
The study will involve a 7 day follow up survey to see if they had experienced complications (runny nose, nasal discomfort, sore throat, epistaxis), what their severity was and how long they lasted for.
- Conditions
- Cardiovascular Diseases
- Being tested
- High-Flow Humidified Nasal Oxygen
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Humidified Nasal OxygenDevice
High-Flow Humidified Nasal Oxygen
| Study group | Role | What they receive |
|---|---|---|
| High-Flow Humidified Nasal Oxygen - TOE participants | Other | High-Flow Humidified Nasal Oxygen - standard care Receives: Device: High-Flow Humidified Nasal Oxygen |
| High-Flow Humidified Nasal Oxygen | Active comparator | High-Flow Humidified Nasal Oxygen - staff volunteers Receives: Device: High-Flow Humidified Nasal Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory tract symptoms
telephone survey after 7 days
Measured: 7 days
Secondary outcomes (1)
severity of respiratory tract symptoms
telephone survey after 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start5 Sep 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 sub group will be recruited: 1. patient undergoing TOE 2. Staff volunteers
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torbay and South Devon NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie Flowers, Dr, Principal investigator, Torbay and South Devon NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619148
- Sponsor's protocol ID
- IRAS-233721
- Other IDs
- 18/LO/1133
- Status last verified
- Jul 2022
- First submitted
- 2 Aug 2018
- Last updated
- 26 Jul 2022
- 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 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Severity of Upper Respiratory Tract Symptoms Associated With The Use of High-Flow Humidified Nasal Oxygen (HFNO)
- ClinicalTrials.gov ID
- NCT03619148
- Acronym / sponsor ID
- IRAS-233721
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Torbay and South Devon NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 7 Aug 2018 (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.
Optiflow (high flow humified nasal oxygen) is used in several settings frequently (ICU, during elective general anaesthesia- commonly here on the TOE list, in certain ENT patients, and more commonly now in obese or obstetric patients for preoxygenation). To the investigators knowledge no one has quantified the common complications associated with it (based on a literature search in November 2017 using PubMed and Google; using the search terms "high flow nasal oxygen" combined with "complications", "side effects", "nasal dryness" and "epistaxis"). The investigators were unable to find any existing research that examined the days following HFNO use and specifically looked for minor side effects) The investigators have had anecdotal feedback from patients that they tend to experience respiratory symptoms post HFNO.
THe investigators would like to determine how often this occurs and how long it lasts for which would be pertinent to consent, and informing patients prior to the procedure, and also serve to improve the literature on this up and coming technique.
Detailed description
The study aims to evaluate what is the frequency and severity of respiratory tract symptoms following the use of high flow nasal humidified oxygen? Participants will be from 2 sub groups:
- Patients already undergoing TOE (as this is the most common and consistent group who have optiflow- about 4-5 patients per week)
- Volunteers (staff) who would agree to experience the optiflow whilst awake for the same period as those undergoing TOE
The study will involve a 7 day follow up survey to see if they had experienced complications (runny nose, nasal discomfort, sore throat, epistaxis), what their severity was and how long they lasted for.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 sub group will be recruited: 1. patient undergoing TOE 2. Staff volunteers
| Arm | Type | Receives |
|---|---|---|
| High-Flow Humidified Nasal Oxygen - TOE participants | Other | Device: High-Flow Humidified Nasal OxygenHigh-Flow Humidified Nasal Oxygen - standard care |
| High-Flow Humidified Nasal Oxygen | Active comparator | Device: High-Flow Humidified Nasal OxygenHigh-Flow Humidified Nasal Oxygen - staff volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers (staff) - from the anaesthetics department and willing to be exposed to HFNO
- Patients listed for all those undergoing elective TOE requiring sedation and use of HFNO
- present at Torbay Hospital
- Greater than 18 years of age. No upper age limit
- Able to give informed consent
Key exclusion criteria (9 listed)
- patient refusal
- lack of capacity
- poor understanding of English
- respiratory tract symptoms
- blocked nostrils
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 Humidified Nasal OxygenHigh-Flow Humidified Nasal Oxygen | Device | High-Flow Humidified Nasal Oxygen, High-Flow Humidified Nasal Oxygen - TOE participants |
Primary outcome
Incidence of respiratory tract symptoms
Time frame: 7 days
telephone survey after 7 days
1 secondary outcome
severity of respiratory tract symptoms
Time frame: 7 days
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 26 Jul 2022.
- 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.
Katie Flowers, Dr principal investigator
Torbay and South Devon NHS Foundation Trust
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 Humidified Nasal Oxygen in people with Cardiovascular Diseases, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 9 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 26 Jul 2022. 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 United Kingdom. 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?
Incidence of respiratory tract symptoms (time frame: 7 days). 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 26 Jul 2022.