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Nasal Oxygen Therapy After Cardiac Surgery (NOTACS)

Primary Purpose

Cardiac Valve Disease, Coronary Artery Disease, Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Flow Nasal Therapy
Sponsored by
Papworth Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Valve Disease focused on measuring High-Flow Nasal Therapy, High-Flow Nasal Oxygen, Cardiac Surgery, Pulmonary Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Papworth Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Standard Oxygen Therapy

High-Flow Nasal Therapy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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
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
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.

Secondary Outcome Measures

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.
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.
Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay .
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
Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke.
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
Incidence of readmission to hospital rate.
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
Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio).
Oxygenation measured by ROX Index (defined as Sp0₂/Fi0₂ to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L
Patient-reported outcomes measured using the EQ-5D-5L questionnaire at baseline, discharge, 30 and 90 days 12. Quality of Suvival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival
Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use.
Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days
Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire.
Patient level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 day

Full Information

First Posted
May 8, 2021
Last Updated
March 24, 2022
Sponsor
Papworth Hospital NHS Foundation Trust
Collaborators
University Hospitals, Leicester, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT05308719
Brief Title
Nasal Oxygen Therapy After Cardiac Surgery
Acronym
NOTACS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust
Collaborators
University Hospitals, Leicester, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Valve Disease, Coronary Artery Disease, Respiratory Failure
Keywords
High-Flow Nasal Therapy, High-Flow Nasal Oxygen, Cardiac Surgery, Pulmonary Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An adaptive, multicentre, parallel group randomised controlled clinical trial with embedded cost-effectiveness analysis.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Oxygen Therapy
Arm Type
No Intervention
Arm Description
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.
Arm Title
High-Flow Nasal Therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Therapy
Intervention Description
High Flow Nasal Oxygen (Airvo2 Device)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
90 days
Title
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
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 days
Title
Incidence of mortality, pulmonary complications, intensive care re-admission rate, length of hospital and intensive care stay .
Description
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
Time Frame
Discharge on average 7 days post operation, 30 and 90 days
Title
Incidence of major complications including sepsis, renal failure, myocardial infarction and stroke.
Description
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
Time Frame
30 and 90 days
Title
Incidence of readmission to hospital rate.
Description
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
Time Frame
90 days
Title
Statistical analysis of oxygenation as measured by the ROX Index (as defined as Sp02/Fi02 to respiratory rate ratio).
Description
Oxygenation measured by ROX Index (defined as Sp0₂/Fi0₂ to respiratory rate ratio) at 2, 6, 12, 24 and 48 hours post-extubation
Time Frame
2,6,12,24,and 48 hours post extubation
Title
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L
Description
Patient-reported outcomes measured using the EQ-5D-5L questionnaire at baseline, discharge, 30 and 90 days 12. Quality of Suvival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
Time Frame
Discharge on average 7 days post operation, 30 and 90 days
Title
Statistical analysis of patient-centered outcomes as measured using the EQ-5D-5L Quality of Survival
Description
Quality of Survival will be as measured using ED-5D-5L Quality adjusted life years (QALYs).
Time Frame
Discharge on average 7 days post operation, 30 and 90 days
Title
Statistical Analysis to determine if prophylactic use of high- flow nasal oxygen reduces health service and resource use.
Description
Health service and resource use measured using Patient and Family Resource Use Questionnaires at baseline, discharge, 30 and 90 days
Time Frame
Discharge on average 7 days post operation, 30 and 90 days
Title
Statistical analysis of patient level of assistance needed with activities of daily living post surgery as measured using BARTHEL questionnaire.
Description
Patient level of assistance needed with activities of daily living, measured using the BARTHEL questionnaire at baseline, discharge, 30 and 90 day
Time Frame
Discharge on average 7 days post operation, 30 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa J Earwaker, MRes
Phone
01223 639712
Email
melissa.earwaker@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa JP Duckworth
Phone
01223 639667
Email
melissa.duckworth@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Klein
Organizational Affiliation
Royal Papworth Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB20AY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa J Earwaker
Phone
01223 639712
Email
melissa.earwaker@nhs.net
First Name & Middle Initial & Last Name & Degree
Melissa JP Duckworth
Phone
01223 639667
Email
Melissa.duckworth@nhs.net
First Name & Middle Initial & Last Name & Degree
Andrew Klein, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Nasal Oxygen Therapy After Cardiac Surgery

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