High Flow Nasal Cannula Versus High Velocity Nasal Insufflation for Weaning

NCT07133698 | Recruiting DMC

• 1 other identifier: WGEK-HVNI-HFNC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In intensive care units (ICUs), approximately 10% to 15%of patients ready to be separated from a ventilator experience extubation failure leading to reintubation. In patients considered at high risk, these rates can even exceed 20%. Because reintubation is associated with particularly high mortality a strategy of oxygenation aimed at avoiding reintubation deserves consideration. Although noninvasive ventilation may prevent postextubation respiratory failure in patients at high risk only 2 small-scale randomized clinical trials (RCTs) have shown decreased reintubation rates compared with standard oxygen. The most recent international clinical practice guidelines recommend the use of noninvasive ventilation to prevent post extubation respiratory failure in patients at high risk of extubation failure (7). However, up until now, no large-scale RCT has demonstrated a significant reduction of reintubation rates with noninvasive ventilation compared with standard oxygen. Thereby, most patients are treated with standard oxygen in clinical practice and only10% of them receive noninvasive ventilation after extubation in the ICU. High-flow nasal cannula (HFNC) oxygen therapy is a new type of respiratory support system which can supply high flow mixed gases through special nasal prongs at a sufficient temperature and humidity for patient comfort. Many studies have confirmed that the comfort and tolerance of HFNC is significantly higher than that of NIV. As an alternative to NIV, HFNC has been shown to be as efficacious as NIV in preventing post-extubation respiratory failure or re-intubation in patients with hypoxemic respiratory failure. High-velocity nasal insufflation, a form of high-flow nasal cannula, focuses on optimum efficiency of the dead-space purge to augment ventilation (removal of carbon dioxide from the dead space between breaths), in addition to providing other effects of high-flow nasal cannula. This is accomplished by use of small-bore nasal cannulae (typically 2.7-mm internal diameter for adult patients) to produce high velocity flow that is approximately 360% greater than that of the larger bore cannulae used in previous studies. According to flow analyses8 and clinical experience, high velocity nasal insufflation typically requires a flow of 25 to 35 L/min in adults to accomplish a complete purge of the extrathoracic anatomic reservoir between breaths.

Conditions

Weaning From Mechanical Ventilation

Keywords

Weaning; HFNC; HVNI; Noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• Successful weaning

  Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH\>7.35 and PaO2\>60 mm Hg in a patient breathing through a mask at FiO2≤0.5

  48 hours

Study Arms (3)

HFNC weaning

EXPERIMENTAL

Device: High Flow nasal Cannula

HVNI weaning

EXPERIMENTAL

Device: High velocity nasal insufflation

Noninvasive ventilation weaning

ACTIVE COMPARATOR

Device: Noninvasive ventilation

Interventions

High Flow nasal Cannula DEVICE

Eligible subjects successfully passing a SBT will be extubated and immediately randomized (1:1:1) to receive one of the following post-extubation respiratory supports for ≥24 hours: HVNI Arm: High-Velocity Nasal Insufflation (Flow: 40-60 L/min, FiO₂ titrated to SpO₂ ≥92%).

HFNC weaning

High velocity nasal insufflation DEVICE

HFNC Arm: High-Flow Nasal Cannula (Flow: 50-60 L/min, FiO₂ titrated to SpO₂ ≥92%).

HVNI weaning

Noninvasive ventilation DEVICE

NIV Arm: Non-Invasive Ventilation (Mode: \[e.g., PSV\], IPAP: \[e.g., 8-12 cmH₂O\], EPAP: \[e.g., 4-6 cmH₂O\], FiO₂ titrated to SpO₂ ≥92%) delivered via \[e.g., oronasal mask\] for ≥16 hours/day initially, with weaning per protocol.

Noninvasive ventilation weaning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) intubated for \>24 hours due to acute respiratory failure, identified as high-risk for extubation failure AND fulfilling standard readiness-to-wean criteria (e.g., resolution of cause of intubation, adequate gas exchange \[P/F ≥150\], hemodynamic stability, spontaneous breathing trial \[SBT\] success)

You may not qualify if:

• Patients with central nervous system disorders unrelated to hypercapnic encephalopathy or hypoxemia.
• Patients with post arrest encephalopathy.
• Patient with previous tracheotomy.
• Patients who received noninvasive ventilation without subsequent intubation.
• Patients with end organ failure.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, 71515, Egypt

RECRUITING

Related Publications (2)

• Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.

  PMID: 30882477 BACKGROUND

• Doshi PB, Whittle JS, Dungan G 2nd, Volakis LI, Bublewicz M, Kearney J, Miller TL, Dodge D, Harsch MR, DeBellis R, Chambers KA. The ventilatory effect of high velocity nasal insufflation compared to non-invasive positive-pressure ventilation in the treatment of hypercapneic respiratory failure: A subgroup analysis. Heart Lung. 2020 Sep-Oct;49(5):610-615. doi: 10.1016/j.hrtlng.2020.03.008. Epub 2020 Apr 6.

  PMID: 32273085 BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• waleed gamal elddin, ass. prof

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

waleed gamal elddin, ass. prof

CONTACT

+201006519722; waleedgamalddin@yahoo.com

Montaser Gamal, Lecturer

CONTACT

+201008951058; Montaser_zahran@yahoo.com

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: Assistant professor of chest diseases

Model Details: Parallel Assignment: Each participant is assigned to only one of the three intervention groups (High flow nasal cannula weaning, High velocity nasal insufflation weaning, noninvasive ventilation weaning) for the entire duration of the weaning period. Outcomes are then compared between these groups.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: February 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)