Noninvasive Technique and High Flow Nasal Oxygen in Respiratory Failure

NCT07521254 | Recruiting DMC

• 1 other identifier: HFNC and NIV in ARF
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

After obtaining Institutional Ethical Committee approval of Faculty of Medicine, Minia University and written informed consent from patients or first- degree relatives, this prospective randomized non-blind comparative study will be conducted in adult intensive care unit (ICU) of Anesthesia, Intensive Care and Pain management department Minia university hospital over a period from September 2025 to April 2026. This study is designed to compare the effectiveness of two protocols of sequential use of High Flow Nasal Cannula (HFNC) and noninvasive ventilation (NIV) versus NIV alone in patients with Acute Respiratory failure (ARF) admitted to the intensive care unit (ICU). The study will include 75 patients of both sexes, classified as ASA class Ⅰ-ⅠⅠⅠ, divided into three groups with 25 patients in each group.

Conditions

Respiratory Failure

Keywords

Noninvasive technique in treatment of respiratory failure; Noninvasive ventilation; Respiratory failure; High flow nasal oxygen

Outcome Measures

Primary Outcomes (1)

• The changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal)

  The primary endpoint is the changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal) from baseline to 24 hours.

  From baseline and thoughout the first 24 hours of the start of the technique

Secondary Outcomes (7)

• Changes in the arterial blood gases values: PH level, PaCO₂

  From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.

• Respiratory rate

  At the baseline then at 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.

• Changes in the dyspnea score

  From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.

• Patient-reported comfort scores

  From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.

• Rate of endotracheal intubation within first 24 hours or continuation on respiratory support after 24 hours.

  During the first 24 hours of the start of the technique

Study Arms (3)

HFNC and NIV 2:1

EXPERIMENTAL

This group will receive first HFNC for 2 hours alternating with NIV for 1 hour. This alternating cycle of HFNC and NIV will be repeated for a total of 16 hours of HFNC and 8 hours of NIV for the first 24 hours

Device: HFNC; Device: NIV

HFNC and NIV 3:3

EXPERIMENTAL

This group will receive first HFNC for 3 hours alternating with NIV for 3 hours. This alternating cycle of HFNC and NIV will be repeated for a total of 12 hours of HFNC and 12 hours of NIV for the first 24 hours

Device: HFNC; Device: NIV

NIV only

EXPERIMENTAL

This group will receive conventional oxygen therapy and NIV as required for acute respiratory failure

Device: NIV

Interventions

HFNC DEVICE

High-flow nasal cannula (HFNC) is a valuable alternative for delivering oxygen therapy in patients with acute respiratory failure. It delivers heated and humidified oxygen at high flow rates-up to 60 L/min-through nasal prongs, allowing for better matching of inspiratory flow, a degree of positive airway pressure, and washout of nasopharyngeal dead space. These features contribute to improved oxygenation and reduced respiratory rate. Additionally, HFNC offers superior comfort and ease of communication compared to traditional masks, which may enhance patient compliance. Importantly, recent evidence suggests that HFNC can also assist in mild hypercapnic conditions by reducing the work of breathing and improving CO₂ clearance in selected patients

HFNC and NIV 2:1; HFNC and NIV 3:3

NIV DEVICE

Noninvasive ventilation (NIV) delivers positive airway pressure either continuously or in a bilevel mode to support ventilation and oxygenation. It has been widely used in managing conditions such as COPD exacerbations, cardiogenic pulmonary edema, and moderate forms of ARDS. NIV enhances alveolar ventilation, unloads respiratory muscles, and improves gas exchange while reducing the need for intubation in many cases. However, its effectiveness depends on proper patient selection and interface tolerance, and it may be less beneficial in patients with excessive secretions, altered mental status, or hemodynamic instability

HFNC and NIV 2:1; HFNC and NIV 3:3; NIV only

Eligibility Criteria

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

You may qualify if:

• Age ≥18 year of both sexes. • Diagnosed with Acute Respiratory Failure (ARF) defined as the combination of a PaO2/FiO2 ratio \< 300 after 15 minutes of conventional oxygen delivered through a face mask, with a FiO2 at least of 50% and respiratory rate \> 30 breaths/min.

You may not qualify if:

• Chronic respiratory disease
• Cardiogenic pulmonary edema
• Life-threatening arrythmias
• Hemodynamic instability requiring vasopressors
• Facial abnormalities preventing NIV or HFNC application
• Glasgow coma score of ≤ 12 points (Teasdale et al. 1974)
• Agitated patients characterized by RASS score (Richmond Agitation Sedation Scale) ≥ +2
• Patients who needed immediate endotracheal intubation
• Pregnant patients

Sponsors & Collaborators

• Minia University: lead
• Minia University Hospital: collaborator

Study Sites (1)

Minya university hospitals

Minya, Minya Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Omyma S Mohamed, Prof.

  ahmed_ezz@mu.edu.eg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omyma S Mohamed, Prof.

CONTACT

0106 1762894; Omaima.Shehata@mu.edu.eg

Shadwa R Mohamed, Ass. Prof.

CONTACT

+20 100 415 7778; Shadwa.Rabie@mu.edu.eg

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: Resident physician

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: April 9, 2026
• Study Start: June 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)