Cardiac Valve Disease, Coronary Artery Disease, Respiratory Failure
Conditions
Keywords
High-Flow Nasal Therapy, High-Flow Nasal Oxygen, Cardiac Surgery, Pulmonary Complications
Brief 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 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.
Interventions
DEVICEHigh Flow Nasal Therapy
High Flow Nasal Oxygen (Airvo2 Device)
Sponsors
University Hospitals, Leicester
King's College London
Papworth Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke. | 30 and 90 days | 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 |
| Incidence of readmission to hospital rate. | 90 days | 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 |
| Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio). | 2,6,12,24,and 48 hours post extubation | Oxygenation measured by ROX Index (defined as Sp0₂/Fi0₂ to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation |
| 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. | 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. |
| Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival | Discharge on average 7 days post operation, 30 and 90 days | Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs). |
| Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use. | Discharge on average 7 days post operation, 30 and 90 days | Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days |
| Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire. | Discharge on average 7 days post operation, 30 and 90 days | Patient level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 day |
| Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L | Discharge on average 7 days post operation, 30 and 90 days | 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). |
| Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay . | Discharge on average 7 days post operation, 30 and 90 days | 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 |
Countries
United Kingdom
Outcome results
None listed