Aortic StenosisHIGH-OXY-TAVRNCT05958537
High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers
A study testing High flow nasal oxygen in people with Aortic Stenosis and Sedation Complication, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Sedation Complication
- 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
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Jul 2024
- 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
- All patients >18 years of age undergoing transfemoral TAVR procedure under local anaesthesia and sedation consenting to participate in the study
Who cannot join
- <18 years and/or refusal to give informed consent for participation General anaesthesia required to perform complex cases of TAVR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement Procedures. Impact on Respiratory Complications and Biomarkers
Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium.
Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 <93% for more than 10 seconds.
Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.
- Conditions
- Aortic Stenosis, Sedation Complication
- Being tested
- High flow nasal oxygen
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygenDevice
Use of High-flow nasal oxygen at 60% 50 L/min.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the intervention group, 50 L/min with 0.6 FiO2 will be administered through a high-flow nasal cannula. Receives: Device: High flow nasal oxygen |
| Control | No intervention | In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of oxygen desaturation episodes
An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds
Measured: up to 24 hours
The number of patients with at least 1 desaturation episode
An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds
Measured: up to 24 hours
Secondary outcomes (6)
Hypoxia
PO2
Measured: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Hipercapnia
PaCO2
Measured: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Trends in plasmatic enolase neurospecific
Study of plasmatic biomarkers of ischaemic damage in brain with Enolase neurospecific
Measured: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Trends in plasmatic Biomarkers of kidney injury
Study of plasmatic biomarkers of ischaemic damage in kidney with creatinine
Measured: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Trends in plasmatic Biomarkers of myocardial injury
Study of plasmatic biomarkers of ischaemic damage in myocardium with troponin and pro-BNP
Measured: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Respiratory depression
Number of respiratory depression episodes requiring manual ventilation.
Measured: During the TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Nov 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958537
- Sponsor's protocol ID
- HCB/2022/1095
- Acronym
- HIGH-OXY-TAVR
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement Procedures. Impact on Respiratory Complications and Biomarkers
- ClinicalTrials.gov ID
- NCT05958537
- Acronym / sponsor ID
- HIGH-OXY-TAVR / HCB/2022/1095
- Conditions
- Aortic Stenosis, Sedation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 24 Jul 2023 (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.
Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium.
Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 <93% for more than 10 seconds.
Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: High flow nasal oxygenIn the intervention group, 50 L/min with 0.6 FiO2 will be administered through a high-flow nasal cannula. |
| Control | No intervention | –In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients >18 years of age undergoing transfemoral TAVR procedure under local anaesthesia and sedation consenting to participate in the study
Key exclusion criteria (1 listed)
- <18 years and/or refusal to give informed consent for participation General anaesthesia required to perform complex cases of TAVR
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 oxygenUse of High-flow nasal oxygen at 60% 50 L/min. | Device | Intervention |
Primary outcome
The number of oxygen desaturation episodes
Time frame: up to 24 hours
An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds
The number of patients with at least 1 desaturation episode
Time frame: up to 24 hours
An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds
6 secondary outcomes
Hypoxia
Time frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Hipercapnia
Time frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Trends in plasmatic enolase neurospecific
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Trends in plasmatic Biomarkers of kidney injury
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Trends in plasmatic Biomarkers of myocardial injury
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Respiratory depression
Time frame: During the TAVI procedure
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 19 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Stenosis and Sedation Complication, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 1 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 19 Dec 2024. 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 Spain. 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?
The number of oxygen desaturation episodes (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 19 Dec 2024.