Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients (CODUET)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AIRVO 2, with conventional symmetric nasal cannula
AIRVO 2, the new asymmetric nasal cannula
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring HFNC, Hypercapnia, COPD
Eligibility Criteria
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
- Home long-term oxygen therapy
Sites / Locations
- IRCCS Policlinico di Sant'OrsolaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HFNC 30 L/min with conventional symmetric nasal cannula
HFNC 30 L/min with new asymmetric nasal cannula
Arm Description
The patients will be asked to breathe with HFNC at flow of 30 L/min with standard interface
The patients will be asked to breathe with HFNC at flow of 30 L/min with the new asymmetric nasal cannula
Outcomes
Primary Outcome Measures
Changes of the partial pressure of carbon dioxide (PaCO2) levels
Arterial Blood Gases will be analyzed from a sample taken from the arterial artery
Secondary Outcome Measures
Respiratory Rate ( RR), (b/min)
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)
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)
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
Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)
Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)
TcPCO2 and SpO2 will be recorded by using a dedicated device (SenTec AG, Therwil, Switzerland)
Dyspnea score
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
this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),
Full Information
NCT ID
NCT05528289
First Posted
August 9, 2022
Last Updated
August 31, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT05528289
Brief Title
Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients
Acronym
CODUET
Official Title
Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
HFNC, Hypercapnia, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC 30 L/min with conventional symmetric nasal cannula
Arm Type
Active Comparator
Arm Description
The patients will be asked to breathe with HFNC at flow of 30 L/min with standard interface
Arm Title
HFNC 30 L/min with new asymmetric nasal cannula
Arm Type
Active Comparator
Arm Description
The patients will be asked to breathe with HFNC at flow of 30 L/min with the new asymmetric nasal cannula
Intervention Type
Device
Intervention Name(s)
AIRVO 2, with conventional symmetric nasal cannula
Other Intervention Name(s)
standard cannula
Intervention Description
The patients will be asked to breathe with HFNC at flow of 30 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 91 and 94%.
Intervention Type
Device
Intervention Name(s)
AIRVO 2, the new asymmetric nasal cannula
Other Intervention Name(s)
"Optiflow+ Duet"
Intervention Description
The patients will be asked to breathe with HFNC at flow of 30 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 91 and 94%.
Primary Outcome Measure Information:
Title
Changes of the partial pressure of carbon dioxide (PaCO2) levels
Description
Arterial Blood Gases will be analyzed from a sample taken from the arterial artery
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
Respiratory Rate ( RR), (b/min)
Description
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)
Time Frame
90 minutes
Title
Tidal Volume ( TV), (mL)
Description
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)
Time Frame
90 minutes
Title
Minute Ventilation (VE), (L/min)
Description
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)
Time Frame
90 minutes
Title
Inspiratory effort quantification
Description
Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)
Time Frame
90 minutes
Title
Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)
Description
TcPCO2 and SpO2 will be recorded by using a dedicated device (SenTec AG, Therwil, Switzerland)
Time Frame
90 minutes
Title
Dyspnea score
Description
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
Time Frame
immediately after intervention
Title
Comfort
Description
this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),
Time Frame
immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Home long-term oxygen therapy
Facility Information:
Facility Name
IRCCS Policlinico di Sant'Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, Prof
Phone
0512143253
Ext
+39
Email
stefano.nava@unibo.it
12. IPD Sharing Statement
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Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients
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