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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05528289
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Study Timeline

• Study Start: 2022-08-04
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-06
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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