Respiratory Failure, Weaning Failure
Conditions
Keywords
HVNI, non-invasive ventilation, weaning failure, extubation, respiratory failure
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.
Interventions
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.
An established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Patient tolerance and comfort | within 72 hours from start of either allocated modality | Rate of tolerance to allocated respiratoy support modality in each arm |
Countries
Egypt
Outcome results
None listed