HVNI for Successful Weaning in Respiratory Failure (REVIVER)

Alexandria University

Status: Enrolling

Conditions: Weaning Failure; Respiratory Failure

Treatments: Device: Non-invasive positive pressure ventilation; Device: High Velocity Nasal Insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT05855213

010594

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

High risk of extubation failure (one or more of the following):

1. Age >65 years old
2. BMI >30
3. APACHE II score at extubation >12
4. ≥2 comorbidities
5. Endotracheal intubation > 7 days
6. ≥1 failed attempts at disconnection from mechanical ventilation
7. Chronic lung disease e.g., COPD, OHS, etc.
8. Underlying left ventricular dysfunction
9. Non-minimal airway secretions

Exclusion criteria

1. Non-respiratory failure patients
2. Patients judged to need a tracheostomy (poor airway reflexes or copious secretions)
3. Patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum)
4. Patients with increased risk of aspiration, agitation, or uncooperativeness
5. End stage disease with life expectancy less than 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

High Velocity Nasal Insufflation (HVNI)

Experimental group

Description:

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: 1. RR\< 25 bpm 2. HR\< 120 bpm 3. SpO2 92-94%

Treatment:

Device: High Velocity Nasal Insufflation

Non-invasive positive pressure ventilation (NIPPV)

Active Comparator group

Description:

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: 1. RR\< 25 bpm 2. HR\< 120 bpm 3. SpO2 92-94%

Treatment:

Device: Non-invasive positive pressure ventilation