HVNI for Successful Weaning in Respiratory Failure

NCT ID: NCT05855213

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-07-31

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.

Conditions

Respiratory Failure; Weaning Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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:

1. RR< 25 bpm

2. HR< 120 bpm

3. SpO2 92-94%

Group Type: EXPERIMENTAL

High Velocity Nasal Insufflation

Intervention Type: 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.

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:

1. RR< 25 bpm

2. HR< 120 bpm

3. SpO2 92-94%

Group Type: ACTIVE_COMPARATOR

Non-invasive positive pressure ventilation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

HVNI; NIPPV

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Salama Sadaka

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Ahmed S Sadaka, PhD

Role: primary

ahmad.sadaka@alexmed.edu.eg

00201005433152

Other Identifiers

010594

Identifier Type: -

Identifier Source: org_study_id