Clinical trial NCT06521489: Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients
Official title: Study of Asymmetrical High Flow Nasal Cannula Oxygenation (HFNCO) vs Standard HFNCO on Cardiac Surgical Patients Postoperatively
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Over the last decade, High Flow Nasal Cannula Oxygenation,(HFNCO) has proven successfully its capability in the management of hypoxemic respiratory failure patients post cardiac surgery. Efficient oxygenation has been recorded in meta-analyses on study population research with BMI \> 30 . Moreover, in a recent meta-analysis, it has been documented that the use of HFNCO required less need for upgrade of respiratory support . Similar findings were documented in a study of two different variations of HFNCO treatment as compared with Conventional oxygen therapy (Venturi mask) .

A modified version (Asymmetrical) of HFNCO came on the surface recently whereas the (L) nasal prong has a larger diameter compared with the (R) prong of the nasal cannula.

Research results on hypoxemic patients and laboratory models also revealed interesting measurements on specific respiratory parameters such as minute volume ventilation, respiratory rate, and work of breathing as compared with conventional HFNCO. In addition, there were documented higher resistance flow rates which achieved higher PEEP rates in favor of lung alveoli.

On the other hand, there exists documentation with positive aspects that support the use of a non-rebreathing mask / Venturi mask or surgical mask fixed on top of nasal prongs of HFNCO to augment the fiO2 which finally ends up on the patient.

Aim of the study. The primary goal of the study is the efficacy of the Asymmetrical HFNCO on cardiac surgical patients post-extubation as compared with Conventional HFNCO The secondary goal of the study is the comparison of initial Asymmetrical HFNCO parameters versus a) the avoidance of upgrading Asymmetrical HFNCO supported by a non-rebreathing mask fixed on top of that, versus b) the avoidance of upgrading Asymmetrical HFNCO to Non-Invasive Ventilation (NIV).

The tertiary goal of the study is the comparison of all three patient groups; a) Asymmetrical HFNCO, 60L/min, FiO2 60%, b) Conventional HFNCO 60l/min, FiO2 60%, c) Conventional oxygen therapy Venturi mask 12l/min, FiO2 60% regarding the use of treatment on patients with ΒΜΙ \> 30 and regarding respiratory parameters (respiratory rate, pO2/ FiO2, spO2, use of accessory muscles, dyspnoea, comfort and tolerance by using the visual analog scale).

Additional goals of the study are to compare all three patient groups regarding ICU Length of Stay, Hospital Length of Stay, rates of ICU re-admission and re-intubation, and any other respiratory / non-respiratory complications and adverse events ( respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, major bleeding - tamponade, cardiac arrest) . Moreover, the rate of failure of the initial treatment will be recorded (as a major measure of treatment efficacy).

Method This is a prospective, non-blinded, randomized study in post-extubated cardiac surgery patients. The study population will consist of three patient groups;

1. Asymmetrical HFNCO, 60l/min, FiO2 60%,
2. Conventional HFNCO 60l/min, FiO2 60%,
3. Conventional oxygen therapy Venturi mask 12l/min, FiO2 60%

Treatment "failure" will be defined as any crossover from one treatment to another due to the patient's respiratory distress and discomfort. To be more specific, switch from Asymmetrical HFNCO to Conventional HFNCO, or switch from Asymmetrical HFNCO to Conventional oxygen therapy supported by a non-rebreathing mask fixed on top of a nasal cannula, or need for more advanced respiratory support such as non-invasive ventilation or invasive mechanical ventilation

Any implemented treatment would also be defined as "failure" when any irreversible (for at least 48 hours) FiO2/gas-mixture flow escalation might be needed, either it is being recorded in study groups 1 \& 2 or control group.

"Failure" would also defined as any irreversible (\> 48 hours) crossover from either the HFNCO group to standard practice (Venturi mask) or the need for more advanced respiratory support such as non-invasive ventilation or invasive mechanical ventilation.

An initial power analysis was based on a predicted, average failure rate of 15% in the HFNCO groups and a failure rate of 51% in the control group; this analysis yielded the need for enrollment of a total of 41 HFNCO patients and 21 controls for alpha = 0.05 and power=0.80. To ensure equal numbers of patients in each one of the 2 HFNCO groups, the authors decided to enroll 42 HFNCO patients (n=21 for each NHF group) and 21 controls, resulting in a total enrollment of 63 patients

Eligibility criteria: Inclusion Criteria:

* Cardiac ICU adult patients
* \>18 years
* After elective or urgent cardiac surgery
* Successful Spontaneous Breathing Trial (SBT) with T-piece and FiO2=60%.
* pO2/ FiO2 \<150
* Hemodynamically stable (160\>SAP\>90mmHg)

Exclusion Criteria:

* Obstructive Sleep Apnea Syndrome supported by CPAP mask on ventilator
* COPD, officially diagnosed, respiratory failure - on exacerbation with serum blood pH \<7,35.
* Patients with tracheostomy,
* DNR status,
* Glasgow Coma Scale score \< 13,
* Insufficient knowledge of the Greek Language
* Visual or hearing impairment.

Primary outcomes:
measure: 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
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
Secondary outcomes:
measure: 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
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: 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
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: Recording of pO2/FiO2 ratio with initial air flow at 60 L/min & 60% fiO2 with Asymmetrical Nasal Cannula High Flow Oxygenation
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: Recording of pO2/FiO2 ratio with initial airflow at 60 L/min & 60% fiO2 with Conventional Nasal Cannula High Flow Oxygenation
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: Recording of pO2/FiO2 ratio with Venturi mask, 60% fiO2, 12l/min
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: 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
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: 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
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, 60% fiO2, 12l/min
timeFrame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
measure: Mobilization of accessory respiratory muscles with initial airflow at 60 L/min & 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation
timeFrame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
measure: Mobilization of accessory respiratory muscles with initial airflow at 60 L/min & 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation.
timeFrame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
measure: Mobilization of accessory respiratory muscles with Venturi mask, 60% fiO2, 12l/min
timeFrame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
measure: 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
timeFrame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
measure: 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
timeFrame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
measure: Comfort and tolerance of treatment with Visual Analogue Scale with Venturi mask, 60% fiO2, 12l/min
timeFrame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
measure: Length of Stay in the ICU
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: Length of Stay in the Hospital
timeFrame: Post cardiothorasic ICU admission period up to actual hospital discharge
measure: Number of participants with death in the cardiothoracic ICU post extubation
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: Number of participants with Atrial Fibrillation in the ICU post extubation
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: Number of participants with any Adverse Events in the ICU (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, major bleeding - tamponade )
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: 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 )
timeFrame: Post cardiothorasic ICU admission period up to 3 months or until actual Hospital discharge
measure: Percentage of participants presenting unsuccessful (failed) implementation of Asymmetrical Nasal Cannula High Flow Oxygenation treatment
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: Percentage of participants presenting unsuccessful (failed) implementation of Conventional Nasal Cannula High Flow Oxygenation treatment
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: Percentage of participants presenting unsuccessful (failed) implementation of Venturi mask oxygen therapy
timeFrame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge]
measure: Number of participants with re-intubation in the ICU
timeFrame: Post cardiothorasic ICU admission period up to 3 months or until actual Hospital discharge
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attiki
Study officials:
affiliation: Evangelismos General Hospital of Athens
name: SPYRIDON A. MENTZELOPOULOS, MD
role: STUDY_DIRECTOR
References:
citation: Shiho D, Kusaka Y, Nakano S, Umegaki O. The short-term efficacy of high flow nasal oxygen therapy on cardiovascular surgical patients: a randomized crossover trial. BMC Anesthesiol. 2022 Oct 29;22(1):331. doi: 10.1186/s12871-022-01883-3.
citation: Wang Y, Zhu J, Wang X, Liu NA, Yang Q, Luan G, Ma X, Liu J. Comparison of High-flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy in Obese Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis. In Vivo. 2021 Sep-Oct;35(5):2521-2529. doi: 10.21873/invivo.12533.
citation: Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. J Crit Care. 2017 Apr;38:123-128. doi: 10.1016/j.jcrc.2016.10.027. Epub 2016 Nov 9.
citation: Boscolo A, Pettenuzzo T, Zarantonello F, Sella N, Pistollato E, De Cassai A, Congedi S, Paiusco I, Bertoldo G, Crociani S, Toma F, Mormando G, Lorenzoni G, Gregori D, Navalesi P. Asymmetrical high-flow nasal cannula performs similarly to standard interface in patients with acute hypoxemic post-extubation respiratory failure: a pilot study. BMC Pulm Med. 2024 Jan 8;24(1):21. doi: 10.1186/s12890-023-02820-x.
citation: Slobod D, Spinelli E, Crotti S, Lissoni A, Galazzi A, Grasselli G, Mauri T. Effects of an asymmetrical high flow nasal cannula interface in hypoxemic patients. Crit Care. 2023 Apr 18;27(1):145. doi: 10.1186/s13054-023-04441-6.
citation: Montiel V, Robert A, Robert A, Nabaoui A, Marie T, Mestre NM, Guillaume M, Laterre PF, Wittebole X. Surgical mask on top of high-flow nasal cannula improves oxygenation in critically ill COVID-19 patients with hypoxemic respiratory failure. Ann Intensive Care. 2020 Sep 29;10(1):125. doi: 10.1186/s13613-020-00744-x.
citation: Egan B, Sharples AP. Molecular responses to acute exercise and their relevance for adaptations in skeletal muscle to exercise training. Physiol Rev. 2023 Jul 1;103(3):2057-2170. doi: 10.1152/physrev.00054.2021. Epub 2022 Nov 17.
citation: Vieira F, Bezerra FS, Coudroy R, Schreiber A, Telias I, Dubo S, Cavalot G, Pereira SM, Piraino T, Brochard LJ. High Flow Nasal Cannula compared to Continuous Positive Airway Pressure: a bench and physiological study. J Appl Physiol (1985). 2022 May 5. doi: 10.1152/japplphysiol.00416.2021. Online ahead of print.
citation: Theologou S, Ischaki E, Zakynthinos SG, Charitos C, Michopanou N, Patsatzis S, Mentzelopoulos SD. High Flow Oxygen Therapy at Two Initial Flow Settings versus Conventional Oxygen Therapy in Cardiac Surgery Patients with Postextubation Hypoxemia: A Single-Center, Unblinded, Randomized, Controlled Trial. J Clin Med. 2021 May 12;10(10):2079. doi: 10.3390/jcm10102079.