Clinical trial NCT05308719: Nasal Oxygen Therapy After Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Valve Disease
Coronary Artery Disease
Respiratory Failure
Keywords: High-Flow Nasal Therapy
High-Flow Nasal Oxygen
Cardiac Surgery
Pulmonary Complications
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University Hospitals, Leicester
name: King's College London
First posted: 2022-04-04
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 90 days
measure: 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
timeFrame: 90 days
Secondary outcomes:
measure: 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.
timeFrame: 30 days
measure: Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay .
timeFrame: Discharge on average 7 days post operation, 30 and 90 days
measure: Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke.
timeFrame: 30 and 90 days
measure: Incidence of readmission to hospital rate.
timeFrame: 90 days
measure: Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio).
timeFrame: 2,6,12,24,and 48 hours post extubation
measure: Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L
timeFrame: Discharge on average 7 days post operation, 30 and 90 days
measure: Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival
timeFrame: Discharge on average 7 days post operation, 30 and 90 days
measure: Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use.
timeFrame: Discharge on average 7 days post operation, 30 and 90 days
measure: Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire.
timeFrame: Discharge on average 7 days post operation, 30 and 90 days
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Royal Papworth Hospital NHS Foundation Trust
name: Andrew Klein
role: PRINCIPAL_INVESTIGATOR
References: