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NCT Number: NCT06204276

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Respiratory rate > 24/min
  • Use of respiratory accessory muscles or paradoxical motion of the abdomen
  • Acute respiratory acidosis with arterial or venous pH < 7.35 and/or PaCO2 > 45 mmHg

Exclusion criteria

  • pH < 7.25
  • Hemodynamic instability requiring vasopressor initiation
  • Persistent hypoxemia despite supplemental oxygen therapy
  • Diminished level of consciousness or uncooperative
  • Active hemoptysis or pneumothorax requiring a chest tube
  • Associated severe chronic neuromuscular disease
  • Pregnancy

Treatment and study plan

Experimental: Asymmetrical high-flow nasal cannula

Device

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

Active comparator: Conventional high-flow nasal cannula

Device

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

Primary outcomes

  1. Diaphragm thickening fraction

    Time frame: 15 minutes

    Diaphragm thickening fraction measured by ultrasound

Secondary outcomes

  1. Parasternal intercostal thickening fraction

    Time frame: 15 minutes

    Parasternal intercostal thickening fraction measured by ultrasound

  2. Parasternal intercostal/diaphragm thickening fraction ratio

    Time frame: 15 minutes

    Contribution between parasternal intercostal and diaphragm thickening fraction

  3. Respiratory rate

    Time frame: 15 minutes

    Respiratory rate

  4. Oxygen saturation

    Time frame: 15 minutes

    Pulse oximetry

  5. Transcutaneous carbon dioxide (CO2) pressure

    Time frame: 15 minutes

    Transcutaneous CO2 monitor

  6. Mean arterial pressure

    Time frame: 15 minutes

    Blood pressure

  7. Heart rate

    Time frame: 15 minutes

    Heart rate

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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