HVNI for Successful Weaning in Respiratory Failure

Not Applicable

Recruiting

• Conditions: Respiratory Failure; Weaning Failure
• Interventions: Device: High Velocity Nasal Insufflation; Device: Non-invasive positive pressure ventilation

• Registration Number: NCT05855213
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-04-08
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11
• Primary Completion: 2024-03
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Velocity Nasal Insufflation (HVNI)	High Velocity Nasal Insufflation	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%
Non-invasive positive pressure ventilation (NIPPV)	Non-invasive positive pressure ventilation	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%

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Hospital stay	Through study completion, an average of 1 year	number of days from hospital admission to 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
Hospital Mortality	Through study completion, an average of 1 year	mortality rate in each allocated arm
Length of ICU stay	Through study completion, an average of 1 year	number of days from ICU admission to discharge
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

Trial Locations

Locations (1)

Chest Diseases Department, Alexandria University Faculty of Medicine; 🇪🇬 Alexandria, Egypt