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Nasal Oxygen Therapy After Cardiac Surgery (NOTACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05308719
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : November 30, 2023
Sponsor:
Collaborators:
University Hospitals, Leicester
King's College London
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Cardiac Valve Disease Coronary Artery Disease Respiratory Failure Device: High Flow Nasal Therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Oxygen Therapy
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
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
High Flow Nasal Oxygen (Airvo2 Device)




Primary Outcome Measures :
  1. Days alive and at home in the first 90 days after surgery, for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications who either receive High flow nasal therapy or Standard oxygen therapy [ Time Frame: 90 days ]
    Number of days at home in the first 90 days after surgery, measured by the patient facing Patient Location and Medication Diary at 90 days

  2. 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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 30 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 30 days.

  2. Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay . [ Time Frame: Discharge on average 7 days post operation, 30 and 90 days ]

    Mortality measured by the incidence of death reported from patient follow-up and medical records at 30 and 90 days.

    Incidence of postoperative pulmonary complications measured using medical notes during primary admission to hospital.

    ICU re-admission rate measured using the in-patient diary eCRF at any time during primary hospital admission Length of ICU stay (days) measured using the in-patient diary eCRF during primary hospital admission Length of hospital stay (days) measured using the in-patient diary eCRF during primary hospital admission


  3. Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke. [ Time Frame: 30 and 90 days ]
    Incidence of stroke measured from patient follow-up and medical records at 30 and 90 days Incidence of sepsis measured from patient follow-up and medical records at 30 and 90 days Incidence of myocardial infarction measured from patient follow-up and medical records at 30 and 90 days

  4. Incidence of readmission to hospital rate. [ Time Frame: 90 days ]
    Incidence of readmission to hospital rate, measured using the in-patient diary eCRF during primary hospital admission and patient location and medication diary for patient completion up to 90 days

  5. Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio). [ Time Frame: 2,6,12,24,and 48 hours post extubation ]
    Oxygenation measured by ROX Index (defined as Sp0₂/Fi0₂ to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation

  6. Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L [ Time Frame: Discharge on average 7 days post operation, 30 and 90 days ]
    Patient-reported outcomes measured using the EQ-5D-5L questionnaire at baseline, discharge, 30 and 90 days 12. Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).

  7. Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival [ Time Frame: Discharge on average 7 days post operation, 30 and 90 days ]
    Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).

  8. Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use. [ Time Frame: Discharge on average 7 days post operation, 30 and 90 days ]
    Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days

  9. Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire. [ Time Frame: Discharge on average 7 days post operation, 30 and 90 days ]
    Patient level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 day



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308719


Contacts
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Contact: Ellen B Temple, MBiol 01223 639809 ellen.temple4@nhs.net
Contact: Melissa JP Duckworth 01223 639667 melissa.duckworth@nhs.net

Locations
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United Kingdom
Royal Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB20AY
Contact: Ellen B Temple, MBiol    01223 639809    ellen.temple4@nhs.net   
Contact: Melissa JP Duckworth    01223 639667    Melissa.duckworth@nhs.net   
Principal Investigator: Andrew Klein, Dr         
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
University Hospitals, Leicester
King's College London
Investigators
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Principal Investigator: Andrew Klein Royal Papworth Hospital NHS Foundation Trust
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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05308719    
Other Study ID Numbers: P02590
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: November 30, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Papworth Hospital NHS Foundation Trust:
High-Flow Nasal Therapy
High-Flow Nasal Oxygen
Cardiac Surgery
Pulmonary Complications
Additional relevant MeSH terms:
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Respiratory Insufficiency
Coronary Artery Disease
Heart Valve Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases