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NCT05308719Completed

Nasal Oxygen Therapy After Cardiac Surgery

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

Source: ClinicalTrials.gov · Last updated 29 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1280 (actual)
First submitted
8 May 2021
Start date
8 Sept 2020
Primary completion date
6 Dec 2024
Lead sponsor
Papworth Hospital NHS Foundation Trust
NCT number
NCT05308719

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1280
  • From 8 Sept 2020 to the primary completion date, 6 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Requiring home oxygen therapy.

Other illness

  • Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate.

Other

  • Deep hypothermic circulatory arrest planned
  • Contraindication to HFNT, e.g. nasal septal defect.
  • Requirement for home ventilatory support (including: HFNT, CPAP, BiPAP)
  • Patients not fluent in English.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Papworth Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.