REVIVER: HVNI for Successful Weaning in Respiratory Failure
Study Details
Study Description
Brief Summary
The goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (HVNI) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (NIPPV) as regards to weaning success rate. The study will recruit those who have been on invasive mechanical ventilation for at least 3 days and with a high risk of weaning failure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). After at least 72 hours from intubation, for respiratoy failure, those who are considered to be eligible for weaning from mechanical ventilation based on the weaning protocol but are at high risk for extubation failure will be randomized to either HVNI or NIPPV. Data on the respiratory and cardiovascular status will be continuously monitored and recorded thereafter.
The primary outcome measure will be failure of either arm within 72 hours of initiation, leading to reintubation (or crossover only from a failed HVNI allocation to NIV based on clinical judgement to avoid reintubation in selected cases). Secondary outcomes to be investigated include: 1) Failure of HVNI or NIPPV after 72 hours from initiation, 2) hospital mortality, 3) length of ICU stay, 4) length of hospital stay, 5) incidence of ventilator associated pneumonia, 6) patient tolerance and comfort, and 7) ICU readmission or mortality at 28-days post hospital discharge.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Velocity Nasal Insufflation (HVNI) HVNI (Precision Flow; Vapotherm®, Inc, Exeter, NH) will be delivered using a small-bore nasal cannula initiated at a flow rate set to 35 L/min, temperature of 35-37°C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature will be titrated to optimize patient's comfort. The target parameters after initiation will be as follows: RR< 25 bpm HR< 120 bpm SpO2 92-94% |
Device: High Velocity Nasal Insufflation
A relatively new respiratory support modality which delivers very high velocity flows. This improves ventilatory efficiency via washing out carbon dioxide occupying the anatomical dead space of the upper airways.
Other Names:
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| Active Comparator: Non-invasive positive pressure ventilation (NIPPV) NIPPV will be initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at IPAP 10-20 cm H2O and EPAP 5-7 cm H2O to be titrated according to patient's response and comfort. FiO2 will be initiated at 1.0 for noninvasive positive-pressure ventilation. The target parameters after initiation will be as follows: RR< 25 bpm HR< 120 bpm SpO2 92-94% |
Device: Non-invasive positive pressure ventilation
An established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Failure of HVNI / NIPPV within 72 hours of initiation [within 72 hours from start of either allocated modality]
need to withdraw allocated respiratory support modality based on predefined arm failure criteria
Secondary Outcome Measures
- Failure of HVNI / NIPPV after 72 hours of initiation [beyond 72 hours from start of either allocated modality]
need to withdraw allocated respiratory support modality based on predefined arm failure criteria
- Length of ICU stay [Through study completion, an average of 1 year]
number of days from ICU admission to discharge
- Length of Hospital stay [Through study completion, an average of 1 year]
number of days from hospital admission to discharge
- Hospital Mortality [Through study completion, an average of 1 year]
mortality rate in each allocated arm
- Patient tolerance and comfort [within 72 hours from start of either allocated modality]
Rate of tolerance to allocated respiratoy support modality in each arm
- Incidence of ventilator associated pneumonia (VAP) [beyond 48 hours from start of invasive mechanical ventilation]
percentage of participants developing VAP
- ICU readmission or mortality post hospital discharge [28 days after hospital discharge]
percentage of participants from each arm needing ICU readmission or dying within 4 weeks of hospital discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
High risk of extubation failure (one or more of the following):
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Age >65 years old
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BMI >30
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APACHE II score at extubation >12
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≥2 comorbidities
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Endotracheal intubation > 7 days
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≥1 failed attempts at disconnection from mechanical ventilation
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Chronic lung disease e.g., COPD, OHS, etc.
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Underlying left ventricular dysfunction
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Non-minimal airway secretions
Exclusion Criteria:
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Non-respiratory failure patients
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Patients judged to need a tracheostomy (poor airway reflexes or copious secretions)
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Patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum)
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Patients with increased risk of aspiration, agitation, or uncooperativeness
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End stage disease with life expectancy less than 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chest Diseases Department, Alexandria University Faculty of Medicine | Alexandria | Egypt |
Sponsors and Collaborators
- Alexandria University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 010594