Nasal high-flow oxygen therapy after cardiac surgery

Conditions

Postoperative pulmonary complications after cardiac surgery Surgery

Edward Litton, Rachael Parke, Shay McGuinness, Sarah Dawson, Sofia S. Villar et al. (100 authors)

JAMA Network Open2026-04-08

10.1001/jamanetworkopen.2026.5447

The international trial of nasal oxygen therapy after cardiac surgery (NOTACS) in patients at high risk of postoperative pulmonary complications: Economic evaluation protocol and analysis plan

Siddesh Shetty, Melissa Duckworth, Richard D. Norman, Jacquita S. Affandi, Sarah Dawson et al. (7 authors)

PLoS ONE2025-01-28

10.1371/journal.pone.0311861

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial

Sarah Dawson, Yi‐Da Chiu, A. A. Klein, Melissa Earwaker, Sofía S. Villar et al. (12 authors)

Trials2024-11-06

10.1186/s13063-024-08538-3

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial.

Dawson SN, Chiu YD, Klein AA, Earwaker M, Villar SS.

2022-08-203 citations

10.1186/s13063-022-06607-z

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial.

Earwaker M, Villar S, Fox-Rushby J, Duckworth M, Dawson S, Steele J, Chiu YD, Litton E, Kunst G, Murphy G, Martinez G, Zochios V, Brown V, Brown G, Klein A.

2022-03-287 citations

10.1186/s13063-022-06180-5

Interventions

The study is an adaptive, multicentre, parallel-group, randomised controlled clinical trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy (HFNT), to standard o

temperature >36°C

stable cardiovascular function

neuromuscular block worn off or reversed

sedation stopped

patients responsive to command and successful trial without mechanical ventilation (defined as oxygen saturation (Sp02)> 93% with inspired oxygen less than or equal to 60%)], they will then be extubat

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 19/10/2023: 1. Aged 18 years or over 2. Undergoing any elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass 3. 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) Previous inclusion criteria from 05/07/2023 to 19/10/2023: 1. Aged 18 years or over 2. Undergoing elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass 3. 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) Previous inclusion criteria: 1. Aged 18 years or over 2. Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination) 3. Have one or more clinical patient-related risk factors for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by the use of antibiotics, body mass index >=35 kg/m², current (within the last 6 weeks) heavy smokers (>10 pack years) 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).

Exclusion criteria

Exclusion criteria: 1. Requiring home oxygen therapy 2. Deep hypothermic circulatory arrest planned 3. Contraindication to HFNT, e.g. nasal septal defect 4. Requirement for home respiratory support (including: CPAP, BiPAP) 5. Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate 6. Patients not fluent in English

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 21/05/2025: 1. Number of days at home without additional support in the first 90 days after surgery, measured by the Patient Location and Medication Diary at 90 days 2. Health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, measured using Patient and Family Resource Use Questionnaires at baseline and 90 days Previous primary outcome measures as of 15/04/2021: 1. Number of days at home in the first 90 days after surgery, measured by the Patient Location and Medication Diary at 90 days 2. Health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, measured using Patient and Family Resource Use Questionnaires at baseline and 90 days Previous primary outcome measures: 1. Number of days at home in the first 90 days after surgery, measured by the Patient Location and Medication Diary at 90 days 2. Health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days	—

Measure

Time frame

Current primary outcome measures as of 21/05/2025: 1. Number of days at home without additional support in the first 90 days after surgery, measured by the Patient Location and Medication Diary at 90 days 2. Health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, measured using Patient and Family Resource Use Questionnaires at baseline and 90 days Previous primary outcome measures as of 15/04/2021: 1. Number of days at home in the first 90 days after surgery, measured by the Patient Location and Medication Diary at 90 days 2. Health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, measured using Patient and Family Resource Use Questionnaires at baseline and 90 days Previous primary outcome measures: 1. Number of days at home in the first 90 days after surgery, measured by the Patient Location and Medication Diary at 90 days 2. Health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days

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Secondary

Measure	Time frame
Current secondary outcome measures as of 15/04/2021: The following are exploratory secondary outcomes of the study: 1. Estimates of the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, calculated by a health economic analysis at 30 days 2. Mortality measured by the incidence of death during primary hospital admission and at patient follow-up at 30 and 90 days 3. Incidence of postoperative pulmonary complications measured using medical notes during primary admission to hospital 4. ICU re-admission rate measured using the in-patient diary eCRF at any time during primary hospital admission 5. Length of ICU stay (days) measured using the in-patient diary eCRF during primary hospital admission 6. Length of hospital stay (days) measured using the in-patient diary eCRF during primary hospital admission 7. Incidence of stroke measured during primary hospital admission and at patient follow-up at 30 and 90 days 8. Incidence of sepsis measured during primary hospital admission and at patient follow-up at 30 and 90 days 9. Incidence of myocardial infarction measured during primary hospital admission and at patient follow-up at 30 and 90 days 10. Oxygenation measured by ROX Index (defined as Sp02/Fi02 to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation 11. Patient-reported outcomes measured using the EQ-5D-5L questionnaire at baseline, discharge, 30 and 90 days 12. Patient-level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 days 13. Quality of survival measured using EQ-5D-5L Quality Adjusted Life Years (QALYs) at baseline, discharge, 30 and 90 days 14. Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days 15. Incidence of readmission to hospital rate, measured using the in-patient diary eCRF during primary hospital admission Previous secondary outcome measure	—

Measure

Time frame

Current secondary outcome measures as of 15/04/2021: The following are exploratory secondary outcomes of the study: 1. Estimates of the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy, calculated by a health economic analysis at 30 days 2. Mortality measured by the incidence of death during primary hospital admission and at patient follow-up at 30 and 90 days 3. Incidence of postoperative pulmonary complications measured using medical notes during primary admission to hospital 4. ICU re-admission rate measured using the in-patient diary eCRF at any time during primary hospital admission 5. Length of ICU stay (days) measured using the in-patient diary eCRF during primary hospital admission 6. Length of hospital stay (days) measured using the in-patient diary eCRF during primary hospital admission 7. Incidence of stroke measured during primary hospital admission and at patient follow-up at 30 and 90 days 8. Incidence of sepsis measured during primary hospital admission and at patient follow-up at 30 and 90 days 9. Incidence of myocardial infarction measured during primary hospital admission and at patient follow-up at 30 and 90 days 10. Oxygenation measured by ROX Index (defined as Sp02/Fi02 to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation 11. Patient-reported outcomes measured using the EQ-5D-5L questionnaire at baseline, discharge, 30 and 90 days 12. Patient-level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 days 13. Quality of survival measured using EQ-5D-5L Quality Adjusted Life Years (QALYs) at baseline, discharge, 30 and 90 days 14. Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days 15. Incidence of readmission to hospital rate, measured using the in-patient diary eCRF during primary hospital admission Previous secondary outcome measure

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Countries

Australia, England, New Zealand, Scotland, United Kingdom, Wales

Outcome results

None listed