Acute Hypoxemic Respiratory FailureNCT05549882
A Novel Index to Predict the Failure of High-flow Nasal Cannula in Patients with Acute Hypoxemic Respiratory Failure
An observational study of Acute Hypoxemic Respiratory Failure, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 21 Jun 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the ICU due to AHRF and treated with HFNC (Optiflow™, Fisher \& Paykel, New Zealand) were screened for enrollment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital, School of Medicine Southeast University Nanjing, China
Nanjing, Jiangsu, 210009
About this study
Official title: A Novel Index to Predict the Failure of High-Flow Nasal Cannula in Patients with Acute Hypoxemic Respiratory Failure
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.
Read the 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. Investigators 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.
Study protocol HFNC therapy was started within 15 minutes after recruitment and initiated with a 30-40 LPM minimum flow. Investigators 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 investigators 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 each 24h pre day following initiation of HFNC treatment until day 7. Variables of pulmonary gas exchange variables with the arterial line were documented at 0, 6, 12 and each 24h pre day following initiation of HFNC treatment until day 7 after initiation of HFNC treatment.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- no intervention
- Keywords
- High-flow nasal cannula, VOX （Volume-OXygenation）
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| HFNC success group | Not described Receives: Other: no intervention | |
| HFNC failure group | HFNC failure was defined as the subsequent need for invasive MV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Oct 2022
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 504 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549882
- Sponsor's protocol ID
- 2020ZDSYLL303-P02
- Status last verified
- Nov 2024
- First submitted
- 18 Sep 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Index to Predict the Failure of High-Flow Nasal Cannula in Patients with Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05549882
- Acronym / sponsor ID
- 2020ZDSYLL303-P02
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- High-flow nasal cannula, VOX （Volume-OXygenation）
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Investigators 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.
Study protocol HFNC therapy was started within 15 minutes after recruitment and initiated with a 30-40 LPM minimum flow. Investigators 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 investigators 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 each 24h pre day following initiation of HFNC treatment until day 7. Variables of pulmonary gas exchange variables with the arterial line were documented at 0, 6, 12 and each 24h pre day following initiation of HFNC treatment until day 7 after initiation of HFNC treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC success group | – | Other: no intervention |
| HFNC failure group | – | –HFNC failure was defined as the subsequent need for invasive MV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU due to AHRF and treated with HFNC (Optiflow™, Fisher \& Paykel, New Zealand) were screened for enrollment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | HFNC success group |
Primary outcome
HFNC failure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypoxemic Respiratory Failure, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFNC failure (time frame: within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.