HVNI for Successful Weaning in Respiratory Failure

Respiratory Failure Clinical Trial

— REVIVER  

Official title:

RolE of High Velocity Nasal Insufflation in imrpoVing wEaning Success in Respiratory Failure Patients (REVIVER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855213
• Other study ID #: 010594
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency
• Weaning Failure

Intervention

Device:
• High Velocity Nasal Insufflation
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 ventilation
An established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure.

Locations

Country	Name	City	State
Egypt	Chest Diseases Department, Alexandria University Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Failure of HVNI / NIPPV after 72 hours of initiation	need to withdraw allocated respiratory support modality based on predefined arm failure criteria	beyond 72 hours from start of either allocated modality
Secondary	Length of ICU stay	number of days from ICU admission to discharge	Through study completion, an average of 1 year
Secondary	Length of Hospital stay	number of days from hospital admission to discharge	Through study completion, an average of 1 year
Secondary	Hospital Mortality	mortality rate in each allocated arm	Through study completion, an average of 1 year
Secondary	Patient tolerance and comfort	Rate of tolerance to allocated respiratoy support modality in each arm	within 72 hours from start of either allocated modality
Secondary	Incidence of ventilator associated pneumonia (VAP)	percentage of participants developing VAP	beyond 48 hours from start of invasive mechanical ventilation
Secondary	ICU readmission or mortality post hospital discharge	percentage of participants from each arm needing ICU readmission or dying within 4 weeks of hospital discharge	28 days after hospital discharge