Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients (CODUET)

Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: AIRVO 2, the new asymmetric nasal cannula; Device: AIRVO 2, with conventional symmetric nasal cannula

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Policlinico di Sant'Orsola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: AIRVO 2, the 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 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%.; Other Names: "Optiflow+ Duet"
Active Comparator: 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	Device: AIRVO 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%.; Other Names: standard cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the partial pressure of carbon dioxide (PaCO2) levels	Arterial Blood Gases will be analyzed from a sample taken from the arterial artery	immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 minutes
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)	90 minutes
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)	90 minutes
Inspiratory effort quantification	Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)	90 minutes
Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)	TcPCO2 and SpO2 will be recorded by using a dedicated device (SenTec AG, Therwil, Switzerland)	90 minutes
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	immediately after intervention
Comfort	this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),	immediately after intervention

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: COPD; HFNC; Hypercapnia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: n° 174/2022/Disp/AOUBo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No