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

NCT05549882 | Completed

• 1 other identifier: 2020ZDSYLL303-P02
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

High-flow nasal cannula; VOX （Volume-OXygenation）

Outcome Measures

Primary Outcomes (1)

• HFNC failure

  HFNC failure was defined as a need for IMV, on account of NIV is not employed as the second line of ventilatory support in the event of HFNC failure, in the participating units

  within 7 days

Study Arms (2)

HFNC success group

Other: no intervention

HFNC failure group

HFNC failure was defined as the subsequent need for invasive MV.

Interventions

no intervention OTHER

no intervention

HFNC success group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the ICU due to AHRF and treated with HFNC (Optiflow™, Fisher \& Paykel, New Zealand) were screened for enrollment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine Southeast University Nanjing, China

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of intensive care unit, Principal investigator, Clinical Professor

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 22, 2022
• Study Start: October 1, 2022
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)