Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients
NCT Number: NCT06521489
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoxemic Respiratory Failure
Interventions: DEVICE: Asymmetrical High Flow Nasal Cannula Oxygenation|DEVICE: Conventional High Flow Nasal Cannula Oxygenation
Sponsor: National and Kapodistrian University of Athens
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-01
Completion Date: 2026-02-28
Locations: Evangelismos General Hospital of Athens, Athens, Attiki, 10676, Greece

Summary:
High-flow oxygen therapy has been applied after extubation in cardiac surgery patients with a well-known successful efficacy. The current authors plan to conduct a prospective, randomized, controlled study of the Asymmetrical device Nasal Cannula High Flow Oxygenation (HFNCO) application on high flow (60L/min) with 60% fiO2 administration versus Conventional device Nasal Cannula High Flow Oxygenation (HFNCO) application on high flow (60L/min) with 60% fiO2 administration and versus Conventional oxygen treatment (Venturi mask) after extubation of patients undergoing elective or non-elective cardiac surgery.

Primary Outcome Measures: Successful weaning (i.e. absence of treatment failure) from Asymmetrical Nasal Cannula High Flow Oxygenation post-extubation from cardiac surgery within at least 48 hours, Successful weaning (i.e. absence of treatment failure as further described in methods) would be defined as = 0 when there would be avoided successfully any alternation with Conventional Nasal Cannula High Flow Oxygenation, Non Invasive Ventilation, or re-intubation

For all groups: Unsuccessful weaning (i.e. actual treatment failure as further described in methods) would be defined as =1 when there would not be avoided any alternation with Conventional Nasal Cannula High Flow Oxygenation, Non Invasive Ventilation or re-intubation., Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
Secondary Outcome Measures: Successful maintenance of Respiration rate within the normal range (12-20/min) on initial airflow at 60 L/min, 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation, Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).

Continuous monitoring and recording of implementation of airflow at 60L/min, 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Successful maintenance of Respiration rate within the normal range (12-20/min) on the initial airflow of 60 L/min, 60% fiO2 with Conventional Nasal Cannula High-Flow Oxygenation, Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).

Continuous monitoring and recording of implementation of airflow at 60L/min, 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min, Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).

Continuous monitoring and recording of implementation of Venturi mask, FiO2: 60%, 15L/min, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Recording of pO2/FiO2 ratio with initial air flow at 60 L/min & 60% fiO2 with Asymmetrical Nasal Cannula High Flow Oxygenation, Continuous monitoring and recording of implementation of Asymmetrical Nasal Cannula High Flow Oxygenation with airflow at 60 L/min \& 60% fiO2, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Recording of pO2/FiO2 ratio with initial airflow at 60 L/min & 60% fiO2 with Conventional Nasal Cannula High Flow Oxygenation, Continuous monitoring and recording of implementation of Conventional Nasal Cannula High Flow Oxygenation with airflow at 60 L/min \& 60% fiO2, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Recording of pO2/FiO2 ratio with Venturi mask, 60% fiO2, 12l/min, Continuous monitoring and recording of implementation of Venturi mask, 60% fiO2, 12l/min, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial airflow at 60 L/min & 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation, Successful maintenance of saturation O2 in Hemoglobulin \> 92% would be defined as = 0.

If saturation O2 \< 92 %, it would be defined as Unsuccessful = 1. Continuous monitoring and recording of implementation of initial airflow at 60 L/min \& 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial airflow at 60 L/min & 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation, Successful maintenance of saturation O2 in Hemoglobulin \> 92% would be defined as = 0.

If saturation O2 \< 92 %, it would be defined as Unsuccessful = 1. Continuous monitoring and recording of implementation of initial airflow at 60 L/min \& 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, 60% fiO2, 12l/min, Successful maintenance of saturation O2 in Hemoglobulin \> 92% would be defined as = 0.

If saturation O2 \< 92 %, it would be defined as Unsuccessful = 1. Continuous monitoring and recording of implementation of Venturi mask, 60% fiO2, 12l/min, Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]|Mobilization of accessory respiratory muscles with initial airflow at 60 L/min & 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation, Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilization and use of accessory respiratory muscles.

Continuous monitoring and recording of implementation of initial airflow at 60 L/min \& 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation, Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)|Mobilization of accessory respiratory muscles with initial airflow at 60 L/min & 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation., Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilization and use of accessory respiratory muscles.

Continuous monitoring and recording of implementation of initial airflow at 60 L/min \& 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation., Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)|Mobilization of accessory respiratory muscles with Venturi mask, 60% fiO2, 12l/min, Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilization and use of accessory respiratory muscles.

Continuous monitoring and recording of implementation of Venturi mask, 60% fiO2, 12l/min, Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)|Comfort and tolerance of treatment with Visual Analogue Scale on Asymmetrical Nasal Cannula High Flow Oxygenation with initial airflow at 60 L/min & 60% fiO2, To monitor and record a patient's comfort with the Visual Analogue Scale diagnostic tool on a scale of 1 to 10. The patients would give the number 10 should they feel comfortable with their respiratory function and have no difficulty breathing. Number 10 on the Scale would mean the best outcome and number 1 would mean the worst outcome respectively, Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)|Comfort and tolerance of treatment with Visual Analogue Scale on Conventional Nasal Cannula High Flow Oxygenation with initial airflow at 60 L/min & 60% fiO2, To monitor and record a patient's comfort with the Visual Analog Scale diagnostic tool on a scale of 1 to 10. The patients would give the number 10 should they feel comfortable with their respiratory function and have no difficulty breathing. Number 10 on the Scale would mean the best outcome and number 1 would mean the worst outcome respectively, Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)|Comfort and tolerance of treatment with Visual Analogue Scale with Venturi mask, 60% fiO2, 12l/min, To monitor and record a patient's comfort with the Visual Analog Scale diagnostic tool on a scale of 1 to 10. The patients would give the number 10 should they feel comfortable with their respiratory function and have no difficulty breathing. Number 10 on the Scale would mean the best outcome and number 1 would mean the worst outcome respectively, Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)|Length of Stay in the ICU, There will be recorded the total length of stay in the ICU since admission post surgery, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Length of Stay in the Hospital, There will be recorded the total length of stay in the hospital since ICU admission, Post cardiothorasic ICU admission period up to actual hospital discharge|Number of participants with death in the cardiothoracic ICU post extubation, There will be recorded the number of participants that will pass away post extubation in the ICU, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Number of participants with Atrial Fibrillation in the ICU post extubation, There will be recorded the number of participants that will present Atrial Fibrillation post extubation in the ICU, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Number of participants with any Adverse Events in the ICU (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, major bleeding - tamponade ), There will be recorded the number of participants that will present any Adverse Events (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, tamponade ) post extubation in the ICU, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Number of participants with any Adverse Events in the Hospital (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, major bleeding - tamponade, cardiac arrest ), There will be recorded the number of participants that will present any Adverse Events (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, tamponade, cardiac arrest) in the Hospital, Post cardiothorasic ICU admission period up to 3 months or until actual Hospital discharge|Percentage of participants presenting unsuccessful (failed) implementation of Asymmetrical Nasal Cannula High Flow Oxygenation treatment, There will be recorded the number of participants who will fail to comply with the treatment due to failing to maintain their respiratory parameters within normal range, or due to presenting intolerance and discomfort to the implementation of Asymmetrical Nasal Cannula High Flow Oxygenation treatment, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Percentage of participants presenting unsuccessful (failed) implementation of Conventional Nasal Cannula High Flow Oxygenation treatment, There will be recorded the number of participants who will fail to comply with the treatment due to failing to maintain their respiratory parameters within normal range, or due to presenting intolerance and discomfort to the implementation of Conventional Nasal Cannula High Flow Oxygenation treatment, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Percentage of participants presenting unsuccessful (failed) implementation of Venturi mask oxygen therapy, There will be recorded the number of participants who will fail to comply with the treatment due to failing to maintain their respiratory parameters within normal range, or due to presenting intolerance and discomfort to the implementation of Venturi mask oxygen therapy, Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]|Number of participants with re-intubation in the ICU, There will be recorded the number of participants that will be re-intubated due to deterioration of their respiratory parameters., Post cardiothorasic ICU admission period up to 3 months or until actual Hospital discharge