HFNC Versus NIV in Hypercapneic COPD Patients

NCT07854210 | Recruiting DMC

• 1 other identifier: MFM-IRB R.25.09.3356
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To compare gas exchange trends, clinical outcomes, and tolerability between HFNC and NIV in COPD patients with mild-to-moderate hypercapnic respiratory failure.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Hypecapneic respiratory failure; HFNC; NIV

Outcome Measures

Primary Outcomes (1)

• treatment failure

  treatment failure defined as the need for escalation from assigned respiratory support to a higher level of ventilatory support during hospitalization. In HFNC group, treatment failure is defined as the need for rescue NIV or invasive mechanical ventilation. In the NIV group ,treatment failure is defined as the need of invasive mechanical ventilation. ( number and percentages of patients experiencing treatment failure in each treatment group)

  From initiation of the assigned respiratory support until hospital discharge, assessed throughout the hospitalization (up to 30 days).

Secondary Outcomes (1)

• serial arterial blood gas parameters at 12, 24 and 48 hours

  at 12, 24, 48 hours after start of respiratory support

Study Arms (2)

Arm 1: high flow nasal canula

EXPERIMENTAL

patients recieve high flow nasal canula oxygen therapy according to study protocol

Device: high flow nasal cannula

Arm 2: non invasive ventilation (NIV)

ACTIVE COMPARATOR

patients recieve NIV according to study protocol

Device: non invasive ventilation

Interventions

high flow nasal cannula DEVICE

high flow nasal canula oxygen therapy according to study protocol

Arm 1: high flow nasal canula

non invasive ventilation DEVICE

non invasive ventilation according to study protocol

Arm 2: non invasive ventilation (NIV)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients hospitalized with mild-to-moderate hypercapnic respiratory failure, defined as arterial pH \[range, e.g., 7.25-7.35\] and PaCO2 \[threshold, e.g., \>45 mmHg and less 60 mmHg\].

Sponsors & Collaborators

• Mohammed Shehta: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Mohammed Shehta, associate professor-chest med.

CONTACT

01004344106; dr_mshehta@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of chest medicine

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: October 2, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

EG (1)