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

NCT ID: NCT06746636

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-05-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Respiratory Failure with Hypoxia

Keywords

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HVNI HFNC HFNO weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Flow reduction

the flow will gradually be reduced by 10 L/ min/h. When it reaches 20 L/min, FiO2 reduction will then begin at 0.1 /h until it reaches 0.3.

Group Type EXPERIMENTAL

High velocity nasal insufflation

Intervention Type DEVICE

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

Oxygen reduction

FiO2 will gradually be reduced by 0.1 /h until it reaches 0.3. At this point, the flow will be reduced by 10 L/min/h until it reaches 20 L/min.

Group Type EXPERIMENTAL

High velocity nasal insufflation

Intervention Type DEVICE

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

Sudden reduction

HVNI will be abruptly discontinued after fulfilling weaning criteria provided that flow and Fio2 are less than 40 L\\min and 40%

Group Type EXPERIMENTAL

High velocity nasal insufflation

Intervention Type DEVICE

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

Flow and oxygen reduction

both flow and FiO2 will be gradually reduced simultaneously at a rate of 10 L/min and 0.1 /h, respectively, until they reach 20 L/min for flow and 0.3 for FiO2

Group Type EXPERIMENTAL

High velocity nasal insufflation

Intervention Type DEVICE

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

Interventions

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High velocity nasal insufflation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Entsar Hsanen

Lecturer of chest diseases and tuberculosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Entsar Hsanen Mohamed, lecturer

Role: CONTACT

Phone: +201019968106

Email: [email protected]

Gamal Mohamed Rabie, professor

Role: CONTACT

Phone: 01155213224

Email: [email protected]

Other Identifiers

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weaning from HVNI

Identifier Type: -

Identifier Source: org_study_id