Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: AIRVO 2, with conventional symmetric nasal cannulaDevice: AIRVO 2, the new asymmetric nasal cannula
- Registration Number
- NCT05528289
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description HFNC 40 L/min with new asymmetric nasal cannula AIRVO 2, with conventional symmetric nasal cannula The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula HFNC 40 L/min with conventional symmetric nasal cannula AIRVO 2, the new asymmetric nasal cannula The patients will be asked to breathe with HFNC at flow of 40 L/min with standard interface
- Primary Outcome Measures
Name Time Method Changes of the partial pressure of carbon dioxide (PaCO2) levels immediately after intervention Arterial Blood Gases will be analyzed from a sample taken from the arterial artery
- Secondary Outcome Measures
Name Time Method Comfort immediately after intervention this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),
Dyspnea score immediately after intervention Dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine
Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2) 90 minutes TcPCO2 and SpO2 will be recorded by using a dedicated device (SenTec AG, Therwil, Switzerland)
Minute Ventilation (VE), (L/min) 90 minutes This parameter will be measured by a bioelectrical impedance monitor and a single-use Pad Set sensor that will be placed on the surface of the chest wall (ExSpiron, Respiratory Motion) Inc. USA)
Inspiratory effort quantification 90 minutes Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)
Respiratory Rate ( RR), (b/min) 90 minutes This parameter will be measured by a bioelectrical impedance monitor and a single-use Pad Set sensor that will be placed on the surface of the chest wall (ExSpiron, Respiratory Motion) Inc. USA)
Tidal Volume ( TV), (mL) 90 minutes This parameter will be measured by a bioelectrical impedance monitor and a single-use Pad Set sensor that will be placed on the surface of the chest wall (ExSpiron, Respiratory Motion) Inc. USA)
Trial Locations
- Locations (1)
IRCCS Policlinico di Sant'Orsola
🇮🇹Bologna, Italy