HVNI for Successful Weaning in Respiratory Failure

NCT05855213 | Unknown

• 1 other identifier: 010594
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Weaning Failure

Keywords

HVNI; non-invasive ventilation; weaning failure; extubation; respiratory failure

Outcome Measures

Primary Outcomes (1)

• Failure of HVNI / NIPPV within 72 hours of initiation

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

  within 72 hours from start of either allocated modality

Secondary Outcomes (7)

• Failure of HVNI / NIPPV after 72 hours of initiation

  beyond 72 hours from start of either allocated modality

• Length of ICU stay

  Through study completion, an average of 1 year

• Length of Hospital stay

  Through study completion, an average of 1 year

• Hospital Mortality

  Through study completion, an average of 1 year

• Patient tolerance and comfort

  within 72 hours from start of either allocated modality

Study Arms (2)

High Velocity Nasal Insufflation (HVNI)

EXPERIMENTAL

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%

Device: High Velocity Nasal Insufflation

Non-invasive positive pressure ventilation (NIPPV)

ACTIVE COMPARATOR

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%

Device: Non-invasive positive pressure ventilation

Interventions

High Velocity Nasal Insufflation DEVICE

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.

Also known as: HVNI

High Velocity Nasal Insufflation (HVNI)

Non-invasive positive pressure ventilation DEVICE

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

Also known as: NIPPV

Non-invasive positive pressure ventilation (NIPPV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk of extubation failure (one or more of the following):
• Age \>65 years old
• BMI \>30
• APACHE II score at extubation \>12
• ≥2 comorbidities
• Endotracheal intubation \> 7 days
• ≥1 failed attempts at disconnection from mechanical ventilation
• Chronic lung disease e.g., COPD, OHS, etc.
• Underlying left ventricular dysfunction
• Non-minimal airway secretions

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: May 11, 2023
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Upon reasonable request

Locations

EG (1)