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NCT Number: NCT06746636

Comparison Between Four Weaning Methods from High-velocity Nasal Insufflation Device in Acute Hypoxemic Respiratory Failure

High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . High-flow nasal oxygen therapy has become an increasingly popular choice of therapy due to the potential complications of invasive ventilation and the frequent uncomfortable or life-threatening adverse effects that are produced in non-invasive ventilation (NIV) . The HFNO allows the modification of only two variables: the percentage of oxygen being delivered and the rate of gas flow . Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is now widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) , and is used in post-extubation treatment, post-cardiothoracic surgery respiratory distress , and respiratory compromise induced by heart failure .

High-velocity nasal insufflation (HVNI) is a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC. HVNI can accomplish a complete purge of extrathoracic dead space and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support.

This study is necessary because, even though studies were being conducted to determine both the optimal technique for HFNO delivery and the clinical setting in which it is most useful, the best strategy for weaning from HVNI remains unknown. It has also not been established at what point a patient should be considered stable enough to attempt for withdrawing the HVNI

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . High-flow nasal oxygen therapy has become an increasingly popular choice of therapy due to the potential complications of invasive ventilation and the frequent uncomfortable or life-threatening adverse effects that are produced in non-invasive ventilation (NIV) . The HFNO allows the modification of only two variables: the percentage of oxygen being delivered and the rate of gas flow . Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is now widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) , and is used in post-extubation treatment , post-cardiothoracic surgery respiratory distress , and respiratory compromise induced by heart failure.

High-velocity nasal insufflation (HVNI) is a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC. HVNI can accomplish a complete purge of extrathoracic dead space and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support .

This study is necessary because, even though studies were being conducted to determine both the optimal technique for HFNO delivery and the clinical setting in which it is most useful, the best strategy for weaning from HVNI remains unknown. It has also not been established at what point a patient should be considered stable enough to attempt to start withdrawing the HVNI

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This study will include Patients over 18 years receiving respiratory support through HVNI for acute hypoxemic respiratory failure
  • Those eligible for weaning according to European Respiratory Society weaning criteria

Exclusion criteria

I. Extensive facial trauma or burn II. Refusal to participate. III. Usual long-term treatment with NIV for chronic disease IV. Tracheotomy or other upper airway disorders

Treatment and study plan

High Velocity Nasal Insufflation

Device
  • HVNI was supplied using a Vapotherm Precision Flow [Precision Flow Plus, Vapotherm, INC. U.S.A. device].

Primary outcomes

  1. Total weaning period (from the first time of being ready to wean till 48h after liberation of HVNI)

    Time frame: 3 days

    period taken for liberation from HVNI

Secondary outcomes

  1. weaning outcome

    Time frame: 1 week

    failed or succeeded liberation

  2. ICU stay

    Time frame: 1month

    period of ICU stay

Study contacts

Contact information is provided by the study sponsor or research team.

Entsar Hsanen Mohamed, lecturer

CONTACT

[email protected]

+201019968106

Gamal Mohamed Rabie, professor

CONTACT

[email protected]

01155213224

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: HVNI

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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