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Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure

The Physiologic Effects of Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure. A Randomized Crossover Study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06204276
Enrollment
40
Registered
2024-01-12
Start date
2024-01-20
Completion date
2024-11-30
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure

Keywords

high-flow nasal cannula, respiratory failure, respiratory muscles, ultrasound

Brief summary

The goal of this randomized crossover physiological study is to evaluate the physiologic effects of asymmetrical nasal cannula and conventional nasal cannula in patients with acute respiratory failure. The main questions it aims to answer are: * Does the asymmetrical high-flow nasal cannula reduce the diaphragm and parasternal intercostal work activity of breathing measured by ultrasound compared to conventional high-flow nasal cannula? * What is the effect of the asymmetrical high-flow nasal cannula on breathing pattern, gas exchange, and hemodynamic variables compared to conventional high-flow nasal cannula? Participants will received asymmetrical high-flow nasal cannula or conventional high-flow nasal cannula at a flow rate of 40 and 60 L/min in a random order.

Detailed description

High-flow nasal cannula (HFNC) is increasingly used in patients with acute respiratory failure. The physiologic benefits of HFNC can be explained via several mechanisms. These mechanisms lead to improve alveolar ventilation and decrease patient's inspiratory effort directly or indirectly. Recent clinical practice guidelines recommended to use HFNC in patients with acute hypoxemic respiratory failure over conventional oxygen therapy (COT) and noninvasive ventilation (NIV). A landmark clinical study demonstrated that patients with acute hypoxemic respiratory failure who received HFNC had better survival than COT and NIV. A systematic review and meta-analysis also demonstrated that HFNC significantly reduced escalation of respiratory support in patients with acute hypoxemic respiratory failure. HFNC can also be an alternative respiratory support in patients with acute on chronic hypercapnic chronic obstructive pulmonary disease (COPD). Several physiological and clinical studies in COPD patients with exacerbations have also suggested that HFNC was not inferior to noninvasive ventilation (NIV) in COPD patients with mild to moderate exacerbation, in terms of gas exchange, treatment failure, intubation rate, and mortality rate. It may be also be used during NIV interruptions or after extubation. Recently, an asymmetrical HFNC interface has been developed with a feature of one prong of smaller diameter and the other prong of larger diameter resulting in an increase in the overall cross-sectional area compared to conventional HFNC interface. An experimental study has shown that asymmetrical nasal cannula potentially increased positive end-expiratory pressure (PEEP) and enhanced carbon dioxide washout compared to conventional nasal cannula. Different respective effects in terms of pressure, resistance, and dead space washout between the two types of cannulas may explain different results, according to the population. The aim of this study is to evaluate the physiologic effects of asymmetrical nasal cannula and conventional nasal cannula on diaphragm and parasternal intercostal activity of breathing measured by ultrasound in patients with acute respiratory failure.

Interventions

DEVICEExperimental: Asymmetrical high-flow nasal cannula

Asymmetrical high-flow nasal cannula will be set at 40 and 60 L/min in a random order. Temperature will be set at 37 degree celsius and inspired oxygen fraction (FiO2) will be adjusted to maintain oxygen saturation by pulse oximetry (SpO2) \>/= 94% in acute hypoxemic patients and between 92-94% in acute hypercapnic COPD patients

DEVICEActive comparator: Conventional high-flow nasal cannula

Conventional high-flow nasal cannula will be set at 40 and 60 L/min in a random order. Temperature will be set at 37 degree celsius and FiO2 will be adjusted to maintain SpO2 \>/= 94% in acute hypoxemic patients and between 92-94% in acute hypercapnic COPD patients

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Patients with acute hypoxemia respiratory failure Inclusion Criteria: * Age \> 18 years old * Acute respiratory failure within 7 days of hospital admission? * Hypoxemia defined by arterial partial pressure of oxygen (PaO2)/FiO2 \< 300 mmHg or SpO2/FiO2 \< 315 * Already supported with HFNC device

Exclusion criteria

* Respiratory acidosis: pH \< 7.30 and PaCO2 \> 45 mmHg * Hemodynamic instability requiring vasopressor initiation * Diminished level of consciousness or uncooperative * Active hemoptysis or pneumothorax requiring a chest tube * Chronic severe neuromuscular disease * Pregnancy Patients with acute hypercapnic COPD Inclusion criteria * Age \> 40 years old * Diagnosed COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline (postbronchodilator forced expiratory volume at 1 second (FEV1)/forced vital capacity (FVC) \< 70%) * Exacerbation requiring hospitalization; at least 2 of the following criteria 1. Respiratory rate \> 24/min 2. Use of respiratory accessory muscles or paradoxical motion of the abdomen 3. Acute respiratory acidosis with arterial or venous pH \< 7.35 and/or PaCO2 \> 45 mmHg

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm thickening fraction15 minutesDiaphragm thickening fraction measured by ultrasound

Secondary

MeasureTime frameDescription
Parasternal intercostal thickening fraction15 minutesParasternal intercostal thickening fraction measured by ultrasound
Parasternal intercostal/diaphragm thickening fraction ratio15 minutesContribution between parasternal intercostal and diaphragm thickening fraction
Respiratory rate15 minutesRespiratory rate
Oxygen saturation15 minutesPulse oximetry
Transcutaneous carbon dioxide (CO2) pressure15 minutesTranscutaneous CO2 monitor
Mean arterial pressure15 minutesBlood pressure
Heart rate15 minutesHeart rate

Countries

Thailand

Contacts

PRINCIPAL_INVESTIGATORNuttapol Rittayamai, M.D.

Siriraj Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026