Oxygen Therapy; Heart SurgeryNCT05384275
High-Flow Aerosol Generation Study
A study testing High Flow Nasal Therapy in people with Oxygen Therapy; Heart Surgery, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study will be measuring aerosol generated from the point of tracheal extubation after cardiac surgery in patients who then receive either high-flow nasal oxygen therapy (HFNT) or standard low-flow oxygen therapy, who have been consented to participate within another randomised controlled trial (The NOTACS Study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Therapy; Heart Surgery
- What is being tested?
- High Flow Nasal Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2021to 31 Jan 2023
- 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
- Aged 18 years or over.
- Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination).
- Have one or more clinical patient-related risk factor for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by use of antibiotics, body mass index ≥35 kg/m2, current (within the last 6 weeks) heavy smokers (> 10 pack years))(26, 27).
- For the purposes of the study, the following definitions apply:
- Asthma is a disease characterized by recurrent attacks of breathlessness and wheezing, and patients will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).
- Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow. The more familiar terms 'chronic bronchitis' and 'emphysema' are no longer used but are now included within the COPD diagnosis. The most common symptoms of COPD are breathlessness, or a 'need for air', excessive sputum production, and a chronic cough. Patients suitable for the NOTACS study will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).
Who cannot join
- Requiring home oxygen therapy.
- Deep hypothermic circulatory arrest planned.
- Contraindication to HFNT, e.g. nasal septal defect.
- Requirement for home respiratory support (including: CPAP, BiPAP).
- Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate.
- Patient's not fluent in English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB20AY
About this study
Official title: Aerosol Generation After Tracheal Extubation With High-flow Nasal Oxygen Therapy Compared With Standard Low-flow Oxygen Therapy: a Randomised Controlled Trial
The study will be measuring aerosol generated from the point of tracheal extubation after cardiac surgery in patients who then receive either high-flow nasal oxygen therapy (HFNT) or standard low-flow oxygen therapy, who have been consented to participate within another randomised controlled trial (The NOTACS Study, IRAS ID 278290). Aerosol generation will be compared at various sizes of particles < 10 microns in size and sampled in different locations in the standardised patient care rooms in the ICU. The rate of change of aerosol generation, maximum aerosol generation and duration of aerosol production greater than background will be investigated. The aim is to compare high-flow and standard low-flow oxygen therapy to determine if there is a difference in aerosol generation between the therapies.
- Conditions
- Oxygen Therapy; Heart Surgery
- Being tested
- High Flow Nasal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal TherapyDevice
High Flow Nasal Oxygen (Airvo2 Device)
| Study group | Role | What they receive |
|---|---|---|
| No intervention: Standard Oxygen Therapy | No intervention | Standard oxygen therapy arm patients will be given 30-40% inspired O2 and flow 2-6 l/min via nasal prongs or non-rebreathing mask (not humidified and not heated) post extubation. Monitoring of saturations, respiratory rate and arterial gases will happen 15 minutes post extubation and then as per local policy thereafter. If saturations < 93% then FiO2 will be increased as per respiratory escalation protocol. Standard oxygen therapy will be given for a minimum of 16 hours post extubation. |
| High-Flow Nasal Therapy | Active comparator | High-flow nasal therapy arm patients will be given AIVRO 2 high flow oxygen therapy machines post extubation, start at 30-40% inspired O2 and flow 30 l/min then up to 50 l/min over 5-10 min. Monitoring of saturations, respiratory rate and arterial gases will happen after 15 minutes post extubation and then as per local policy thereafter. If saturations < 93% then increase FiO2 as per respiratory escalation protocol. High flow nasal therapy will be given for a minimum of 16 hours post extubation. Receives: Device: High Flow Nasal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess aerosol generation as measured by total exposure level of 0.3 micron particles during tracheal extubation and for 1 hour afterwards (study period) at 50 cm to the side of the patient's head.
This will be measured by the total particle count using area under the curve (AUC) over the 1 hour timeframe.
Measured: 1 hour
Secondary outcomes (5)
To assess the time needed for particle counts to return to baseline level, measuring particles size 0.3, 0.5, 1.0, 2.5, 5.0 and 10.0 microns during tracheal extubation and for 1 hour afterwards.
Measured at 50 cm to the side of the patient's head, at 50 cm from the top of the patient's head and by the patient's feet.
Measured: 1 hour
To assess total aerosol generation measuring particles size 0.5, 1.0, 2.5, 5.0 and 10.0 microns during tracheal extubation and for 1 hour afterwards.
Measured at 50 cm to the side of the patient's head, at 50 cm from the top of the patient's head and by the patient's feet.
Measured: 1 hour
To assess total aerosol generation measuring particle size 0.3 microns during tracheal extubation and for 1 hour afterwards at 50 cm from the top of the patient's head and by the patient's feet.
Measured: 1 hour
To assess the peak particle count of 0.3, 0.5, 1.0, 2.5, 5.0 and 10.0 micron during tracheal extubation and for 1 hour afterwards at 50 cm to the side of the patient's head, 50 cm from the top of the patient's head and by the patient's feet.
Measured: 1 hour
To measure CO2 levels during tracheal extubation and for 1 hour afterwards.
Measured at 50 cm to the side of the patient's head, at 50 cm from the top of the patient's head and by the patient's feet. A CO2 counter will be placed next to each of the particle counter devices.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start17 May 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Therapy; Heart SurgeryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew Klein, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384275
- Sponsor's protocol ID
- P02723
- Status last verified
- Nov 2023
- First submitted
- 17 May 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosol Generation After Tracheal Extubation With High-flow Nasal Oxygen Therapy Compared With Standard Low-flow Oxygen Therapy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05384275
- Acronym / sponsor ID
- P02723
- Conditions
- Oxygen Therapy; Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 20 May 2022 (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.
The study will be measuring aerosol generated from the point of tracheal extubation after cardiac surgery in patients who then receive either high-flow nasal oxygen therapy (HFNT) or standard low-flow oxygen therapy, who have been consented to participate within another randomised controlled trial (The NOTACS Study, IRAS ID 278290). Aerosol generation will be compared at various sizes of particles < 10 microns in size and sampled in different locations in the standardised patient care rooms in the ICU. The rate of change of aerosol generation, maximum aerosol generation and duration of aerosol production greater than background will be investigated. The aim is to compare high-flow and standard low-flow oxygen therapy to determine if there is a difference in aerosol generation between the therapies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention: Standard Oxygen Therapy | No intervention | –Standard oxygen therapy arm patients will be given 30-40% inspired O2 and flow 2-6 l/min via nasal prongs or non-rebreathing mask (not humidified and not heated) post extubation. Monitoring of saturations, respiratory rate and arterial gases will happen 15 minutes post extubation and then as per local policy thereafter. If saturations < 93% then FiO2 will be increased as per respiratory escalation protocol. Standard oxygen therapy will be given for a minimum of 16 hours post extubation. |
| High-Flow Nasal Therapy | Active comparator | Device: High Flow Nasal TherapyHigh-flow nasal therapy arm patients will be given AIVRO 2 high flow oxygen therapy machines post extubation, start at 30-40% inspired O2 and flow 30 l/min then up to 50 l/min over 5-10 min. Monitoring of saturations, respiratory rate and arterial gases will happen after 15 minutes post extubation and then as per local policy thereafter. If saturations < 93% then increase FiO2 as per respiratory escalation protocol. High flow nasal therapy will be given for a minimum of 16 hours post extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or over.
- Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination).
- Have one or more clinical patient-related risk factor for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by use of antibiotics, body mass index ≥35 kg/m2, current (within the last 6 weeks) heavy smokers (> 10 pack years))(26, 27).
- Asthma is a disease characterized by recurrent attacks of breathlessness and wheezing, and patients will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).
- Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow. The more familiar terms 'chronic bronchitis' and 'emphysema' are no longer used but are now included within the COPD diagnosis. The most common symptoms of COPD are breathlessness, or a 'need for air', excessive sputum production, and a chronic cough. Patients suitable for the NOTACS study will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).
Key exclusion criteria (6 listed)
- Requiring home oxygen therapy.
- Deep hypothermic circulatory arrest planned.
- Contraindication to HFNT, e.g. nasal septal defect.
- Requirement for home respiratory support (including: CPAP, BiPAP).
- Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate.
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 TherapyHigh Flow Nasal Oxygen (Airvo2 Device) | Device | High-Flow Nasal Therapy |
Primary outcome
To assess aerosol generation as measured by total exposure level of 0.3 micron particles during tracheal extubation and for 1 hour afterwards (study period) at 50 cm to the side of the patient's head.
Time frame: 1 hour
This will be measured by the total particle count using area under the curve (AUC) over the 1 hour timeframe.
5 secondary outcomes
To assess the time needed for particle counts to return to baseline level, measuring particles size 0.3, 0.5, 1.0, 2.5, 5.0 and 10.0 microns during tracheal extubation and for 1 hour afterwards.
Time frame: 1 hour
To assess total aerosol generation measuring particles size 0.5, 1.0, 2.5, 5.0 and 10.0 microns during tracheal extubation and for 1 hour afterwards.
Time frame: 1 hour
To assess total aerosol generation measuring particle size 0.3 microns during tracheal extubation and for 1 hour afterwards at 50 cm from the top of the patient's head and by the patient's feet.
Time frame: 1 hour
To assess the peak particle count of 0.3, 0.5, 1.0, 2.5, 5.0 and 10.0 micron during tracheal extubation and for 1 hour afterwards at 50 cm to the side of the patient's head, 50 cm from the top of the patient's head and by the patient's feet.
Time frame: 1 hour
To measure CO2 levels during tracheal extubation and for 1 hour afterwards.
Time frame: 1 hour
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 28 Nov 2023.
- Individual participant dataSharing planned: No
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.
Andrew Klein principal investigator
Royal Papworth Hospital
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 Therapy in people with Oxygen Therapy; Heart Surgery, run by Papworth Hospital 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 6 inclusion and 6 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 28 Nov 2023. 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?
To assess aerosol generation as measured by total exposure level of 0.3 micron particles during tracheal extubation and for 1 hour afterwards (study period) at 50 cm to the side of the patient's head. (time frame: 1 hour). 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 28 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.