Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes of the partial pressure of carbon dioxide (PaCO2) levels
Study Overview
Brief Summary
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and respiratory effort.
The aim of this randomized crossover physiological study is to investigate the effects on PaCO2 levels of two different nasal cannula ('Optiflow + Duet' interface vs "standard" nasal interface) in COPD patients with persistent hypercapnia following an acute severe exacerbation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inpatients recovering from an acute exacerbation of their disease
- •Persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH>7,35 and
- •PaCO2>50 mmHg on 3 consecutive measurements)
- •Informed consent
Exclusion Criteria
- •Body Mass Index (BMI) > 30 kg/m2;
- •Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
- •Chest wall disease
- •Heart failure
- •Severe hemodynamic instability ( need for amine support)
- •Acute coronary syndrome (ACS)
- •Severe arrhythmia
- •Renal insufficiency
- •Patients unable to protect respiratory airways
- •Respiratory arrest and need for endotracheal intubation
- •Pregnancy
- •Need for sedation
Arms & Interventions
HFNC 40 L/min with conventional symmetric nasal cannula
The patients will be asked to breathe with HFNC at flow of 40 L/min with standard interface
Intervention: AIRVO 2, the new asymmetric nasal cannula (Device)
HFNC 40 L/min with new asymmetric nasal cannula
The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula
Intervention: AIRVO 2, with conventional symmetric nasal cannula (Device)
Outcomes
Primary Outcomes
Changes of the partial pressure of carbon dioxide (PaCO2) levels
Time Frame: immediately after intervention
Arterial Blood Gases will be analyzed from a sample taken from the arterial artery
Secondary Outcomes
- Comfort(immediately after intervention)
- Dyspnea score(immediately after intervention)
- Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)(90 minutes)
- Minute Ventilation (VE), (L/min)(90 minutes)
- Inspiratory effort quantification(90 minutes)
- Respiratory Rate ( RR), (b/min)(90 minutes)
- Tidal Volume ( TV), (mL)(90 minutes)
Investigators
dr. Stefano Nava
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna