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

Not Applicable

Recruiting

• Conditions: Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure

• Registration Number: NCT06204276
• Lead Sponsor: Siriraj Hospital

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Study Start: 2024-01-20
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25
• Primary Completion: 2025-01-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Diaphragm thickening fraction	15 minutes	Diaphragm thickening fraction measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
Parasternal intercostal thickening fraction	15 minutes	Parasternal intercostal thickening fraction measured by ultrasound
Parasternal intercostal/diaphragm thickening fraction ratio	15 minutes	Contribution between parasternal intercostal and diaphragm thickening fraction
Mean arterial pressure	15 minutes	Blood pressure
Transcutaneous carbon dioxide (CO2) pressure	15 minutes	Transcutaneous CO2 monitor
Heart rate	15 minutes	Heart rate
Oxygen saturation	15 minutes	Pulse oximetry
Respiratory rate	15 minutes	Respiratory rate

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand