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

NCT06746636 | Not Yet Recruiting FDA Device

• 1 other identifier: weaning from HVNI
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Respiratory Failure with Hypoxia

Keywords

HVNI; HFNC; HFNO; weaning

Outcome Measures

Primary Outcomes (1)

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

  period taken for liberation from HVNI

  3 days

Secondary Outcomes (2)

• weaning outcome

  1 week

• ICU stay

  1month

Study Arms (4)

Flow reduction

EXPERIMENTAL

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.

Device: High velocity nasal insufflation

Oxygen reduction

EXPERIMENTAL

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.

Device: High velocity nasal insufflation

Sudden reduction

EXPERIMENTAL

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

Device: High velocity nasal insufflation

Flow and oxygen reduction

EXPERIMENTAL

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

Device: High velocity nasal insufflation

Interventions

High velocity nasal insufflation DEVICE

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

Flow and oxygen reduction; Flow reduction; Oxygen reduction; Sudden reduction

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Entsar Hsanen Mohamed, lecturer

CONTACT

+201019968106; entsar.hsanen@aun.edu.eg

Gamal Mohamed Rabie, professor

CONTACT

01155213224; Gamalagmy135@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of chest diseases and tuberculosis

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: May 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12