asal high-flow oxygen therapy after cardiac surgery

Not Applicable

• Conditions: Surgery; Postoperative pulmonary complications after cardiac surgery

• Registration Number: ISRCTN14092678
• Lead Sponsor: Royal Papworth Hospital NHS Foundation Trust

Brief Summary

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35987698/ (added 22/08/2022) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35346339/ (added 13/07/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-13
• Last Update Posted: 22 April 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

Current inclusion criteria as of 19/10/2023:
1. Aged 18 years or over
2. Undergoing any elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
3. 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)

Previous inclusion criteria from 05/07/2023 to 19/10/2023:
1. Aged 18 years or over
2. Undergoing elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
3. 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)

Previous inclusion criteria:
1. Aged 18 years or over
2. Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination)
3. Have one or more clinical patient-related risk factors for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by the use of antibiotics, body mass index >=35 kg/m², current (within the last 6 weeks) heavy smokers (>10 pack years)

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 Criteria

1. Requiring home oxygen therapy
2. Deep hypothermic circulatory arrest planned
3. Contraindication to HFNT, e.g. nasal septal defect
4. Requirement for home respiratory support (including: CPAP, BiPAP)
5. Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate
6. Patients not fluent in English

Study & Design

• Study Type: Interventional
• Study Design: Not specified