Status:
COMPLETED
High-Flow Aerosol Generation Study
Lead Sponsor:
Papworth Hospital NHS Foundation Trust
Conditions:
Oxygen Therapy; Heart Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will be measuring aerosol generated from the point of tracheal extubation after cardiac surgery in patients who then receive either high-flow nasal oxygen therapy (HFNT) or standard low-flow...
Eligibility Criteria
Inclusion
- Aged 18 years or over.
- Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination).
- 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))(26, 27).
- 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
- Requiring home oxygen therapy.
- Deep hypothermic circulatory arrest planned.
- Contraindication to HFNT, e.g. nasal septal defect.
- Requirement for home respiratory support (including: CPAP, BiPAP).
- Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate.
- Patient's not fluent in English.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05384275
Start Date
May 17 2021
End Date
January 31 2023
Last Update
November 28 2023
Active Locations (1)
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1
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB20AY