Nasal Oxygen Therapy After Cardiac Surgery (NOTACS)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    850
  • sponsor
    Papworth Hospital NHS Foundation Trust
Updated on 21 April 2022
body mass index
pulmonary disease

Summary

NOTACS aims to determine if prophylactic use of high-flow nasal therapy (for a minimum of 16 hours after tracheal extubation) 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.

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.

Details
Condition Cardiac Valve Disease, Coronary Artery Disease, Respiratory Failure
Treatment High Flow Nasal Therapy
Clinical Study IdentifierNCT05308719
SponsorPapworth Hospital NHS Foundation Trust
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 years or over
Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery or both)
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
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