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

NCT05528289 | Completed

• 1 other identifier: n° 174/2022/Disp/AOUBo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

HFNC; Hypercapnia; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Respiratory Rate ( RR), (b/min)

  90 minutes

• Tidal Volume ( TV), (mL)

  90 minutes

• Minute Ventilation (VE), (L/min)

  90 minutes

• Inspiratory effort quantification

  90 minutes

• Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)

  90 minutes

Study Arms (2)

HFNC 40 L/min with conventional symmetric nasal cannula

ACTIVE COMPARATOR

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

HFNC 40 L/min with new asymmetric nasal cannula

ACTIVE COMPARATOR

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

Interventions

AIRVO 2, with conventional symmetric nasal cannula DEVICE

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%.

Also known as: standard cannula

HFNC 40 L/min with new asymmetric nasal cannula

AIRVO 2, the new asymmetric nasal cannula DEVICE

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%.

Also known as: "Optiflow+ Duet"

HFNC 40 L/min with conventional symmetric nasal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: September 6, 2022
• Study Start: August 4, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

IT (1)