HFNC Versus NIV in Hypercapneic COPD Patients

ConditionCOPD (Chronic Obstructive Pulmonary Disease)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorMohammed Shehta

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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].

Disqualifiers

patients with altered mental state, confused, severe agitation or not cooperative were excluded. Also, severe acidosis (pH <7.25), hemodynamic instability, facial trauma or surgery, cases with severe nasal deformity, immediate indication for invasive ventilation, patient refusal, cases with respiratory rate more than 35 breaths per minute. Respiratory exhaustion, excess use of respiratory accessory muscles, Patients with breathing disorders during sleep as well as cases of upper airway obstruction and patients with history of chronic home ventilation prior admission were another items for exclusion

Trial design

Design model

Parallel

Treatments tested in this trial

high flow nasal cannula
Device
high flow nasal canula oxygen therapy according to study protocol
non invasive ventilation
Device
non invasive ventilation according to study protocol

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Arm 1: high flow nasal canulaExperimental treatment 1 intervention

Group B: Arm 2: non invasive ventilation (NIV)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

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

Secondary outcomes

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

serial arterial blood gas parameters (pH, PaCO2, HCO3) at 12, 24 and 48 hours;

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohammed Shehta

Lead sponsor

Mansoura University

Sponsor institution

Source ClinicalTrials.gov

Apply now