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

Sponsor
Southeast University, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05549882
Collaborator
(none)
504
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Detailed Description

Study design This is a multi-center prospective observational study performed over a 12-month period (from August 2022 to August 2023). The research premise was granted approval by the local Ethics Committee (2020ZDSYLL303-P02).

VOX index The VOX index was defined as the ratio of SpO2/FiO2 over VT. We briefly interrupted HFNC (3 minutes) to measure VT using a mechanical ventilator (SV800, Mindray) in noninvasive ventilation (NIV) mode, as an "NIV test". Inspiratory support was set at 5 cmH2O and 5 cmH2O positive end-expiratory pressure level for all patients, and initial oxygen concentration was set as in HFNC. NIV was delivered through a face mask (ZS-MZ-A, Zhongshan Medical) and a double-pipe system, while minimizing leaks. In consideration of variations in VT, we recorded mean VT and respiratory rate for 1 minute under stable conditions. (Figure 1) Study protocol HFNC therapy was started within 15 minutes after recruitment and initiated with a 30-40 LPM minimum flow. We adjusted FiO2 as suitable, targeting SpO2 of 92% or more, and the rate of flow set on the basis of the physician's decision. HFNC discontinuation and invasive mechanical ventilation (IMV) initiation were based on the intubation criteria defined in our clinical protocol, finial decisions were made by the physicians in charge, who were blinded to the VT during NIV test. HFNC failure was defined as a need for IMV, on account of NIV is not employed as the second line of ventila,ory support in the event of HFNC failure, in the participating units. Patient demographics, comorbidities, and chest radiographs prior to HFNC initiation were documented upon inclusion into the research analysis. The acute physiologic assessment and chronic health evaluation II (APACHE II) score along with the sequential organ failure assessment score (SOFA) were documented based on the highest scores in the 24h previous HFNC initiation. The time of HFNC onset was defined as 0h. Vital signs; HFNC settings including FiO2, flow rate, and temperature; clinical respiratory variables including RR, VT, and SpO2; diaphragmatic ultrasonography including diaphragmatic displacement, diaphragm thickness (tdi), and Δtdi% (was calculated as [tdi end-inspiration-tdi end-expiration/tdi end-expiration] ×100) were recorded at 0, 2, 6, 12, 18, and 24h following initiation of HFNC treatment. Variables of pulmonary gas exchange variables with the arterial line were documented at 0, 6, 12, and 24h after initiation of HFNC treatment.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
504 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Novel Index to Predict the Failure of High-Flow Nasal Cannula in Patients With Acute Hypoxemic Respiratory Failure
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
HFNC success group

Other: no intervention
no intervention

HFNC failure group

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

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. HFNC failure [within 7 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • We enrolled consecutive patients between 18 years and 80 years of age, if they met all the following criteria: a respiratory rate of more than 25 breaths per minute, a ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mmHg or less while the patient was breathing oxygen at a flow rate of 10 liters per minute or more, a partial pressure of arterial carbon dioxide (PaCO2) not higher than 45 mmHg
Exclusion Criteria:
  • The main exclusion criteria were patients who could strongly benefit from NIV (ie, those with underlying chronic lung disease, or exacerbation of asthma, with cardiogenic pulmonary oedema, severe neutropenia (<500/mm3), or who were neuromuscular diseases such as myasthenia gravis and Guillain-Barre syndrome); those with severe shock, defined as a vasopressor dose of more than 0.3 μg/kg per min norepinephrine-equivalent to maintain systolic blood pressure at higher than 90 mmHg; those with impaired consciousness with a Glasgow coma score of 12 or lower; those with an urgent need for intubation (ie, respiratory or cardiac arrest, severe hypoxemia defined as PaO2/FiO2 lower than 50mmHg despite maximum oxygen support); those with contraindication to NIV (ie, unresolved vomiting, upper airway obstruction, hematemesis, recent major esophageal and upper abdominal surgery, or severe facial trauma) and high-flow nasal cannula (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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Southeast University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ling Liu, Director of intensive care unit, Principal investigator, Clinical Professor, Southeast University, China
ClinicalTrials.gov Identifier:
NCT05549882
Other Study ID Numbers:
  • 2020ZDSYLL303-P02
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022