HVNI for Successful Weaning in Respiratory Failure (REVIVER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Weaning Failure
• Intervention / Treatment: Device: High Velocity Nasal Insufflation; Device: Non-invasive positive pressure ventilation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Chest Diseases Department, Alexandria University Faculty of Medicine
    • Contact: Ahmed S Sadaka, PhD; Phone Number: 00201005433152; Email: ahmad.sadaka@alexmed.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Velocity Nasal Insufflation (HVNI); 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: RR< 25 bpm; HR< 120 bpm; SpO2 92-94%	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.; Other Names: HVNI
Active Comparator: Non-invasive positive pressure ventilation (NIPPV); 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: RR< 25 bpm; HR< 120 bpm; SpO2 92-94%	Device: Non-invasive positive pressure ventilation; An established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure.; Other Names: NIPPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Length of ICU stay	number of days from ICU admission to discharge	Through study completion, an average of 1 year
Length of Hospital stay	number of days from hospital admission to discharge	Through study completion, an average of 1 year
Hospital Mortality	mortality rate in each allocated arm	Through study completion, an average of 1 year
Patient tolerance and comfort	Rate of tolerance to allocated respiratoy support modality in each arm	within 72 hours from start of either allocated modality
Incidence of ventilator associated pneumonia (VAP)	percentage of participants developing VAP	beyond 48 hours from start of invasive mechanical ventilation
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

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: respiratory failure; non-invasive ventilation; extubation; weaning failure; HVNI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 010594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No