Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients

NCT06521489 | Active Not Recruiting DMC

• 1 other identifier: NKUAthensGreece
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• 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

  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

  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

  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

  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

  Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]

Study Arms (3)

Study Group 1, Asymmetrical HFNCO

ACTIVE COMPARATOR

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.

Device: Asymmetrical High Flow Nasal Cannula Oxygenation

Study Group 2, Conventional HFNCO

ACTIVE COMPARATOR

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.

Device: Conventional High Flow Nasal Cannula Oxygenation

Control Group

NO INTERVENTION

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

Interventions

Asymmetrical High Flow Nasal Cannula Oxygenation DEVICE

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

Study Group 1, Asymmetrical HFNCO

Conventional High Flow Nasal Cannula Oxygenation DEVICE

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

Study Group 2, Conventional HFNCO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Evangelismos General Hospital of Athens

Athens, Attica, 10676, Greece

Location

Related Publications (9)

• 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.

  PMID: 36309660 BACKGROUND

• 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.

  PMID: 34410938 BACKGROUND

• 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.

  PMID: 27886577 BACKGROUND

• 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.

  PMID: 38191347 BACKGROUND

• 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.

  PMID: 37072854 BACKGROUND

• 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.

  PMID: 32990864 BACKGROUND

• 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.

  PMID: 36395350 BACKGROUND

• 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.

  PMID: 35511720 BACKGROUND

• 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.

  PMID: 34066244 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• SPYRIDON A. MENTZELOPOULOS, MD

  Evangelismos General Hospital of Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Stavros Theologou, RN, Deputy Nurse in Charge - Cardiac Surgery ICU, MSc, MHM, PhD

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 26, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)