Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Different Modalities of Combined Noninvasive Ventilation With High Flow Nasal Oxygen Versus Noninvasive Ventilation Alone in Acute Respiratory Failure

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Minya university hospitals
RECRUITING
Minya
Contact Information
Primary
Omyma S Mohamed, Prof.
Omaima.Shehata@mu.edu.eg
0106 1762894
Backup
Shadwa R Mohamed, Ass. Prof.
Shadwa.Rabie@mu.edu.eg
+20 100 415 7778
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 75
Treatments
Experimental: HFNC and NIV 2:1
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
Experimental: HFNC and NIV 3:3
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
Experimental: NIV only
This group will receive conventional oxygen therapy and NIV as required for acute respiratory failure
Sponsors
Collaborators: Minia University Hospital
Leads: Minia University

This content was sourced from clinicaltrials.gov