Clinical trial NCT05855213: HVNI for Successful Weaning in Respiratory Failure
Official title: RolE of High Velocity Nasal Insufflation in imrpoVing wEaning Success in Respiratory Failure Patients (REVIVER)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Weaning Failure
Keywords: HVNI
non-invasive ventilation
weaning failure
extubation
respiratory failure
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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). Allocation arm failure , assessed after 72 hours of extubation, will be the primary outcome. Cross-over from HVNI to NIPPV may be allowed in case of HVNI failure and potential benefit as judged by the treating clinical team prior to reintubation.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure of HVNI / NIPPV within 72 hours of initiation
timeFrame: within 72 hours from start of either allocated modality
Secondary outcomes:
measure: Failure of HVNI / NIPPV after 72 hours of initiation
timeFrame: beyond 72 hours from start of either allocated modality
measure: Length of ICU stay
timeFrame: Through study completion, an average of 1 year
measure: Length of Hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Hospital Mortality
timeFrame: Through study completion, an average of 1 year
measure: Patient tolerance and comfort
timeFrame: within 72 hours from start of either allocated modality
measure: Incidence of ventilator associated pneumonia (VAP)
timeFrame: beyond 48 hours from start of invasive mechanical ventilation
measure: ICU readmission or mortality post hospital discharge
timeFrame: 28 days after hospital discharge
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Chest Diseases Department, Alexandria University Faculty of Medicine
Study officials:
References: