HVNI for Successful Weaning in Respiratory Failure

Alexandria University40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Failure Weaning Failure

Interventions

High Velocity Nasal InsufflationDEVICE

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.

Non-invasive positive pressure ventilationDEVICE

An established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, Egypt

RECRUITING

Outcomes

Primary Outcomes

Failure of HVNI / NIPPV within 72 hours of initiation

need to withdraw allocated respiratory support modality based on predefined arm failure criteria

Time frame: within 72 hours from start of either allocated modality

Secondary Outcomes

Failure of HVNI / NIPPV after 72 hours of initiation

need to withdraw allocated respiratory support modality based on predefined arm failure criteria

Time frame: beyond 72 hours from start of either allocated modality

Length of ICU stay

number of days from ICU admission to discharge

Time frame: Through study completion, an average of 1 year

Length of Hospital stay

number of days from hospital admission to discharge

Time frame: Through study completion, an average of 1 year

Hospital Mortality

mortality rate in each allocated arm

Time frame: Through study completion, an average of 1 year

Patient tolerance and comfort

Rate of tolerance to allocated respiratoy support modality in each arm

Time frame: within 72 hours from start of either allocated modality

Incidence of ventilator associated pneumonia (VAP)

percentage of participants developing VAP

Time frame: beyond 48 hours from start of invasive mechanical ventilation

ICU readmission or mortality post hospital discharge

Data from ClinicalTrials.gov

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