CompletedNot Applicable

A Novel Index to Predict the Failure of High-flow Nasal Cannula in Patients with Acute Hypoxemic Respiratory Failure

China504 participantsStarted 2022-10-01

Plain-language summary

High-flow nasal cannula (HFNC) is increasingly used in patients with acute hypoxemic respiratory failure (AHRF) and has been shown to improve outcome in specific patient categories, including community acquired pneumonia and after extubation. Since HFNC failure and delayed intubation is associated with adverse clinical outcome, predicting HFNC failure is of clinical importance. In patients with pneumonia and hypoxemic failure treated with HFNC, the ROX index (SpO2/FiO2 over respiratory rate), has been validated to predict the risk for endotracheal intubation. Increased respiratory rate, an important component of ROX, is used as an estimate for high respiratory drive, although it is well known that respiratory rate is insensitive to early changes in respiratory drive. Indeed, it has been shown that ROX worked best only after 12 hours after HFNC initiation. Earlier and more sensitive predictors of HFNC failure would be of clinical importance. Initially, elevated respiratory drive increases tidal volume (VT), but not respiratory rate. In addition, high VT has been linked to patient self-inflicted lung injury (P-SILI) and such may increase intubation rate in patients with AHRF. Taken together, from a physiological perspective, elevated TV may be a better predictor for HFNC failure compared to respiratory rate. Hence, we report an approach to measure VT generated by patients supported with HFNC and establish a novel index named VOX (Volume-OXygenation) based on VT to predict HFNC failure in patients with AHRF.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients between 18 years and 80 years of age * RR \> 25 breaths per minute * PaO2/FiO2 ≤ 300 mmHg while breathing oxygen at a flow rate ≥ 10 liters per minute and PaCO2 ≤ 45 mmHg Exclusion Criteria: * Patients could strongly benefit from NIV (ie, patients with underlying chronic lung disease, or exacerbation of asthma, with cardiogenic pulmonary oedema, severe neutropenia (\<500/mm3), or neuromuscular diseases such as myasthenia gravis and Guillain-Barre syndrome) * Patients with severe shock, defined as a vasopressor dose\> 0.3 μg/kg per min norepinephrine-equivalent to maintain SBP \> 90 mmHg * Patients with impaired consciousness with a GCS ≤ 12 * Patients with an urgent need for intubation (ie, respiratory or cardiac arrest, severe hypoxemia defined as PaO2/FiO2 \< 50mmHg despite maximum oxygen support) * Patients with contraindication to NIV (ie, unresolved vomiting, upper airway obstruction, hematemesis, recent major esophageal and upper abdominal surgery, or severe facial trauma) and HFNC (ie, epistaxis, nasal obstruction or acceptance of nasal surgery), intubated for diagnostic or therapeutic procedures (fiberoptic bronchoscopy or surgery), and patients with a 'do not resuscitate or intubate' order

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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What they're measuring

HFNC failure

Timeframe: within 7 days

Trial details

NCT IDNCT05549882

SponsorSoutheast University, China

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-21

View on ClinicalTrials.gov More Acute Hypoxemic Respiratory Failure trials