Nasal Oxygen Therapy After Cardiac Surgery

NCT05308719 | Completed DMC

• 1 other identifier: P02590
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiac Valve Disease; Coronary Artery Disease; Respiratory Failure

Keywords

High-Flow Nasal Therapy; High-Flow Nasal Oxygen; Cardiac Surgery; Pulmonary Complications

Outcome Measures

Primary Outcomes (2)

• Days alive and at home without additional support in the first 90 days after surgery, for adults at high risk of postoperative pulmonary complications undergoing cardiac surgery who either receive High Flow Nasal Oxygen Therapy or Standard Oxygen Therapy

  Number of days at home without additional support in the first 90 days after surgery (relative to baseline location and support), measured by the patient facing Patient Location and Medication Diary at 90 days

  90 days

• Incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy for patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications at 90 days

  Health Economic analysis to estimate the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus Standard therapy at 90 days from the view point of the public sector, NHS and patient, measured by using Patient and Family Resource Use patient facing Questionnaires at 90 days.

  90 days

Secondary Outcomes (9)

• Estimates of the incremental cost-effectiveness and cost-utility of High flow nasal therapy versus standard oxygen therapy for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications at 30 days.

  30 days

• Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay .

  Discharge on average 7 days post operation, 30 and 90 days

• Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke.

  30 and 90 days

• Incidence of readmission to hospital rate.

  90 days

• Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio).

  2,6,12,24,and 48 hours post extubation

Study Arms (2)

Standard Oxygen Therapy

NO INTERVENTION

Standard oxygen therapy arm patients will be given 30-40% inspired O2 and flow 2-6 l/min via nasal prongs or non-rebreathing mask (not humidified and not heated) post extubation. Monitoring of saturations, respiratory rate and arterial gases will happen 15 minutes post extubation and then as per local policy thereafter. If saturations \< 93% then FiO2 will be increased as per respiratory escalation protocol. Standard oxygen therapy will be given for a minimum of 16 hours post extubation.

High-Flow Nasal Therapy

OTHER

High-flow nasal therapy arm patients will be given AIVRO 2 high flow oxygen therapy machines post extubation, start at 30-40% inspired O2 and flow 30 l/min then up to 50 l/min over 5-10 min. Monitoring of saturations, respiratory rate and arterial gases will happen after 15 minutes post extubation and then as per local policy thereafter. If saturations \< 93% then increase FiO2 as per respiratory escalation protocol. High flow nasal therapy will be given for a minimum of 16 hours post extubation.

Device: High Flow Nasal Therapy

Interventions

High Flow Nasal Therapy DEVICE

High Flow Nasal Oxygen (Airvo2 Device)

High-Flow Nasal Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• University Hospitals, Leicester: collaborator
• King's College London: collaborator

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB20AY, United Kingdom

Location

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Andrew Klein

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: April 4, 2022
• Study Start: September 8, 2020
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)