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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,280
High Flow Nasal Oxygen (Airvo2 Device)
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
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
Time frame: 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.
Time frame: 90 days
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.
Time frame: 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
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.
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
Time frame: 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
Time frame: 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
Time frame: 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).
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
Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
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.
Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days
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.
Patient level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 day
Time frame: Discharge on average 7 days post operation, 30 and 90 days
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