Status:
COMPLETED
Nasal Oxygen Therapy After Cardiac Surgery
Lead Sponsor:
Papworth Hospital NHS Foundation Trust
Collaborating Sponsors:
University Hospitals, Leicester
King's College London
Conditions:
Cardiac Valve Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 respirato...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT05308719
Start Date
September 8 2020
End Date
December 6 2024
Last Update
May 29 2025
Active Locations (1)
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1
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB20AY