Clinical trial NCT06204276: Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure
Official title: The Physiologic Effects of Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure. A Randomized Crossover Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Acute Hypercapnic Respiratory Failure
Keywords: high-flow nasal cannula
respiratory failure
respiratory muscles
ultrasound
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

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

Primary outcomes:
measure: Diaphragm thickening fraction
timeFrame: 15 minutes
Secondary outcomes:
measure: Parasternal intercostal thickening fraction
timeFrame: 15 minutes
measure: Parasternal intercostal/diaphragm thickening fraction ratio
timeFrame: 15 minutes
measure: Respiratory rate
timeFrame: 15 minutes
measure: Oxygen saturation
timeFrame: 15 minutes
measure: Transcutaneous carbon dioxide (CO2) pressure
timeFrame: 15 minutes
measure: Mean arterial pressure
timeFrame: 15 minutes
measure: Heart rate
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Nuttapol Rittayamai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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