Cardiac Valve DiseaseNOTACSNCT05308719
Nasal Oxygen Therapy After Cardiac Surgery
A study testing High Flow Nasal Therapy in people with Cardiac Valve Disease and Coronary Artery Disease, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
NOTACS aims to determine if prophylactic use of high-flow nasal therapy (for a minimum of 16 hours after tracheal extubation, inclusive of up to one hour off randomised therapy for transfers around the hospital and/or physio mobilisation) increases days at home in the first 90 days after surgery, for adult patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Disease, Coronary Artery Disease, Respiratory Failure
- 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
- 1,280 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Sep 2020to 6 Dec 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
- Aged 18 years or over.
- Undergoing any elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
- Have one or more clinical risk factors 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 smoker (> 10 pack years)) (47, 48).
- 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 13 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 ventilatory support (including: HFNT, CPAP, BiPAP)
- Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate.
- Patients 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: Effect of High-Flow Nasal Therapy on Patient-Centered Outcomes in Patients at High Risk of Postoperative Pulmonary Complications After Cardiac Surgery: A Multicentre Randomised Trial
NOTACS aims to determine if prophylactic use of high-flow nasal therapy (for a minimum of 16 hours after tracheal extubation, inclusive of up to one hour off randomised therapy for transfers around the hospital and/or physio mobilisation) increases days at home in the first 90 days after surgery, for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications. The study also incorporates a health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy at 90 days, from the view-point of the public sector, NHS and patients.
Read the detailed description
Patients undergoing cardiac surgery are at significant risk of postoperative pulmonary complications that may lead to prolonged ICU and hospital stay and increase mortality. The incidence of respiratory complications may be three to four times more common in patients with intrinsic respiratory disease and lower airway obstruction (including asthma or chronic obstructive pulmonary disease (COPD)), or obese patients or current heavy smokers (> 10 pack years).
High-flow nasal therapy (HFNT) is increasingly used as a non-invasive form of respiratory support. It delivers low level, flow-dependent positive airway pressure, and is much better tolerated by patients than alternatives such as continuous positive airway pressure (CPAP) or non-invasive ventilation. Patients can talk, eat, drink and walk whilst using HFNT. However, there is equipoise regarding its prophylactic use and effect on important patient-centred outcomes. Before the intervention is recommended for routine NHS use in cardiac surgery patients at high risk of pulmonary complications, whether it improves patient-related outcomes and is cost effective in a UK setting needs to be assessed.
- Being tested
- High Flow Nasal Therapy
- Keywords
- High-Flow Nasal Therapy, High-Flow Nasal Oxygen, Cardiac Surgery, Pulmonary Complications
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease, Respiratory Insufficiency
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 |
|---|---|---|
| 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 | Other | 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.
Days alive and at home without additional support in the first 90 days after surgery, for adults at high risk of postoperative pulmonary complications undergoing cardiac surgery who either receive High Flow Nasal Oxygen Therapy or Standard Oxygen Therapy
Number of days at home without additional support in the first 90 days after surgery (relative to baseline location and support), measured by the patient facing Patient Location and Medication Diary at 90 days
Measured: 90 days
Incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy for patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications at 90 days
Health Economic analysis to estimate the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy at 90 days from the view point of the public sector, NHS and patient, measured by using Patient and Family Resource Use patient facing Questionnaires at 90 days.
Measured: 90 days
Secondary outcomes (9)
Estimates of the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus standard oxygen therapy for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications at 30 days.
Health Economic analysis to estimate the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy at 90 days from the view point of the public sector, NHS and patient, measured by using Patient and Family Resource Use patient facing Questionnaires at 30 days.
Measured: 30 days
Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay .
Mortality measured by the incidence of death reported from patient follow-up and medical records at 30 and 90 days.
Incidence of postoperative pulmonary complications measured using medical notes during primary admission to hospital.
ICU re-admission rate measured using the in-patient diary eCRF at any time during primary hospital admission Length of ICU stay (days) measured using the in-patient diary eCRF during primary hospital admission Length of hospital stay (days) measured using the in-patient diary eCRF during primary hospital admission
Measured: Discharge on average 7 days post operation, 30 and 90 days
Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke.
Incidence of stroke measured from patient follow-up and medical records at 30 and 90 days Incidence of sepsis measured from patient follow-up and medical records at 30 and 90 days Incidence of myocardial infarction measured from patient follow-up and medical records at 30 and 90 days
Measured: 30 and 90 days
Incidence of readmission to hospital rate.
Incidence of readmission to hospital rate, measured using the in-patient diary eCRF during primary hospital admission and patient location and medication diary for patient completion up to 90 days
Measured: 90 days
Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio).
Oxygenation measured by ROX Index (defined as Sp0₂/Fi0₂ to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation
Measured: 2,6,12,24,and 48 hours post extubation
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L
Patient-reported outcomes measured using the EQ-5D-5L questionnaire at baseline, discharge, 30 and 90 days 12. Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
Measured: Discharge on average 7 days post operation, 30 and 90 days
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival
Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
Measured: Discharge on average 7 days post operation, 30 and 90 days
Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use.
Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days
Measured: Discharge on average 7 days post operation, 30 and 90 days
Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire.
Patient level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 day
Measured: Discharge on average 7 days post operation, 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start8 Sep 2020
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Valve DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University Hospitals, Leicester, King's College London
- Responsible party
- Sponsor
- Investigators
- Andrew Klein, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308719
- Sponsor's protocol ID
- P02590
- Acronym
- NOTACS
- Status last verified
- May 2025
- First submitted
- 8 May 2021
- Last updated
- 29 May 2025
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Flow Nasal Therapy on Patient-Centered Outcomes in Patients at High Risk of Postoperative Pulmonary Complications After Cardiac Surgery: A Multicentre Randomised Trial
- ClinicalTrials.gov ID
- NCT05308719
- Acronym / sponsor ID
- NOTACS / P02590
- Keywords
- High-Flow Nasal Therapy, High-Flow Nasal Oxygen, Cardiac Surgery, Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- University Hospitals, Leicester, King's College London
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 4 Apr 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.
NOTACS aims to determine if prophylactic use of high-flow nasal therapy (for a minimum of 16 hours after tracheal extubation, inclusive of up to one hour off randomised therapy for transfers around the hospital and/or physio mobilisation) increases days at home in the first 90 days after surgery, for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications. The study also incorporates a health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy at 90 days, from the view-point of the public sector, NHS and patients.
Detailed description
Patients undergoing cardiac surgery are at significant risk of postoperative pulmonary complications that may lead to prolonged ICU and hospital stay and increase mortality. The incidence of respiratory complications may be three to four times more common in patients with intrinsic respiratory disease and lower airway obstruction (including asthma or chronic obstructive pulmonary disease (COPD)), or obese patients or current heavy smokers (> 10 pack years).
High-flow nasal therapy (HFNT) is increasingly used as a non-invasive form of respiratory support. It delivers low level, flow-dependent positive airway pressure, and is much better tolerated by patients than alternatives such as continuous positive airway pressure (CPAP) or non-invasive ventilation. Patients can talk, eat, drink and walk whilst using HFNT. However, there is equipoise regarding its prophylactic use and effect on important patient-centred outcomes. Before the intervention is recommended for routine NHS use in cardiac surgery patients at high risk of pulmonary complications, whether it improves patient-related outcomes and is cost effective in a UK setting needs to be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other | 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 (5 listed)
- Aged 18 years or over.
- Undergoing any elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
- Have one or more clinical risk factors 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 smoker (> 10 pack years)) (47, 48).
- 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 13 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 ventilatory support (including: HFNT, 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
Days alive and at home without additional support in the first 90 days after surgery, for adults at high risk of postoperative pulmonary complications undergoing cardiac surgery who either receive High Flow Nasal Oxygen Therapy or Standard Oxygen Therapy
Time frame: 90 days
Number of days at home without additional support in the first 90 days after surgery (relative to baseline location and support), measured by the patient facing Patient Location and Medication Diary at 90 days
Incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy for patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications at 90 days
Time frame: 90 days
Health Economic analysis to estimate the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy at 90 days from the view point of the public sector, NHS and patient, measured by using Patient and Family Resource Use patient facing Questionnaires at 90 days.
9 secondary outcomes
Estimates of the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus standard oxygen therapy for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications at 30 days.
Time frame: 30 days
Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay .
Time frame: Discharge on average 7 days post operation, 30 and 90 days
Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke.
Time frame: 30 and 90 days
Incidence of readmission to hospital rate.
Time frame: 90 days
Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio).
Time frame: 2,6,12,24,and 48 hours post extubation
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L
Time frame: Discharge on average 7 days post operation, 30 and 90 days
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival
Time frame: Discharge on average 7 days post operation, 30 and 90 days
Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use.
Time frame: Discharge on average 7 days post operation, 30 and 90 days
Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire.
Time frame: Discharge on average 7 days post operation, 30 and 90 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 29 May 2025.
- 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.
Andrew Klein principal investigator
Papworth Hospital 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 Nasal Therapy in people with Cardiac Valve Disease and Coronary Artery Disease, 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 5 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 29 May 2025. 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?
Days alive and at home without additional support in the first 90 days after surgery, for adults at high risk of postoperative pulmonary complications undergoing cardiac surgery who either receive High Flow Nasal Oxygen Therapy or Standard Oxygen Therapy (time frame: 90 days). 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 29 May 2025.