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

Chronic Obstructive Pulmonary Disease Clinical Trial

— CODUET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528289
• Other study ID #: n° 174/2022/Disp/AOUBo
• Status: Completed
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: June 2024
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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%.
• 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%.

Locations

Country	Name	City	State
Italy	IRCCS Policlinico di Sant'Orsola	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Inspiratory effort quantification	Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)	90 minutes
Secondary	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
Secondary	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
Secondary	Comfort	this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),	immediately after intervention