Chronic Obstructive Pulmonary Disease
Conditions
Keywords
HFNC, Hypercapnia, COPD
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
Interventions
DEVICEAIRVO 2, with conventional symmetric nasal cannula
The patients will be asked to breathe with HFNC at flow of 40 L/min with the standard cannula The size of nasal cannula will be selected to occlude patient's nostril of about 2/3. Temperature will be set according to the patient's tolerance starting from 31°C, up to 37°C, while FiO2 is adjusted to maintain SpO2 between 88 and 92%.
The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula The size of nasal cannula will be selected to occlude patient's nostril of about 2/3. Temperature will be set according to the patient's tolerance starting from 31°C, up to 37°C, while FiO2 is adjusted to maintain SpO2 between 88 and 92%.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| Comfort | immediately after intervention | this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable), |
| 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) |
Countries
Italy
Outcome results
None listed