Minya university hospitals
Minya, Minya Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07521254
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Minya, Minya Governorate, Egypt
Location status: Recruiting
After failure of a trial of treatment with conventional oxygen therapy delivered through a face mask, with a FiO2 at least of 50% for 15 minutes, patients will be assigned into one of three groups:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: From baseline and thoughout the first 24 hours of the start of the technique
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.
Time frame: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Changes in the arterial blood gases values: PH level, PaCO₂ from baseline to 6, 12, 18 and 24h.
Time frame: At the baseline then at 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Respiratory rate
Time frame: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Borg dyspnea score
Time frame: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
VAS (Visual Analogue Score)
Time frame: During the first 24 hours of the start of the technique
Rate of endotracheal intubation within first 24 hours or continuation on respiratory support after 24 hours.
Time frame: Total days of hospital stay starting from the day of starting the intervention protocol until patient discharge from ICU or death (up to 100 days)
Length of stay in ICU and hospital
Time frame: Total days starting from the start of intervention protocol until patient death (if occurred) (Up to 100 days)
Time to death in ICU/hospital
Contact information is provided by the study sponsor or research team.
Omyma S Mohamed, Prof.
CONTACT
Shadwa R Mohamed, Ass. Prof.
CONTACT
Minia University
Other
Different Modalities of Combined Noninvasive Ventilation With High Flow Nasal Oxygen Versus Noninvasive Ventilation Alone in Acute Respiratory Failure
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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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