Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients

NCT ID: NCT06521489

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-02-28

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

Conditions

Hypoxemic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study Group 1, Asymmetrical HFNCO

The intervention involves implementing the Asymmetrical High Flow Oxygenation Nasal Cannula as an oxygen treatment at Study Group 1. In contrast, oxygen supply was provided via conventional High Flow Nasal Cannula as a standard oxygen patients' treatment

The first Study Group will include patients on Asymmetrical High Flow Nasal Cannula Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.

Group Type: ACTIVE_COMPARATOR

Asymmetrical High Flow Nasal Cannula Oxygenation

Intervention Type: DEVICE

Asymmetrical High Flow Nasal Cannula Oxygenation will be implemented in this study group. (1st study group, 60l/min airflow, 60% fiO2)

Study Group 2, Conventional HFNCO

The intervention involves implementing High Flow Nasal Cannula Oxygenation as an oxygen treatment in Study Group 2.

The second Study Group will include patients on Conventional High Flow Nasal Cannula Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.

Group Type: ACTIVE_COMPARATOR

Conventional High Flow Nasal Cannula Oxygenation

Intervention Type: DEVICE

Conventional High Flow Nasal Cannula Oxygenation will be implemented in this study group. (2nd study group, 60l/min airflow, 60% fiO2)

Control Group

No Intervention: Control group In the third group (control group) all patients will receive oxygen treatment according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 12L/min.

In this group, all patients will receive the usual standard of care, with no other interventions included

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Asymmetrical High Flow Nasal Cannula Oxygenation

Asymmetrical High Flow Nasal Cannula Oxygenation will be implemented in this study group. (1st study group, 60l/min airflow, 60% fiO2)

Intervention Type: DEVICE

Conventional High Flow Nasal Cannula Oxygenation

Conventional High Flow Nasal Cannula Oxygenation will be implemented in this study group. (2nd study group, 60l/min airflow, 60% fiO2)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Stavros Theologou

Principal Investigator, Stavros Theologou, RN, Deputy Nurse in Charge - Cardiac Surgery ICU, MSc, MHM, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SPYRIDON A. MENTZELOPOULOS, MD

Role: STUDY_DIRECTOR

Evangelismos General Hospital of Athens

Locations

Evangelismos General Hospital of Athens

Athens, Attica, Greece

Countries

Greece

References

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Reference Type: BACKGROUND

PMID: 36309660 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 34410938 (View on PubMed)

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.

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Reference Type: BACKGROUND

PMID: 38191347 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37072854 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32990864 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36395350 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35511720 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34066244 (View on PubMed)

Other Identifiers

NKUAthensGreece

Identifier Type: -

Identifier Source: org_study_id