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Completed

NCT Number: NCT05528289

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico di Sant'Orsola

Bologna, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

Other names: standard 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%.

Other names: "Optiflow+ Duet"

Primary outcomes

  1. Changes of the partial pressure of carbon dioxide (PaCO2) levels

    Time frame: immediately after intervention

    Arterial Blood Gases will be analyzed from a sample taken from the arterial artery

Secondary outcomes

  1. Respiratory Rate ( RR), (b/min)

    Time frame: 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)

  2. Tidal Volume ( TV), (mL)

    Time frame: 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)

  3. Minute Ventilation (VE), (L/min)

    Time frame: 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)

  4. Inspiratory effort quantification

    Time frame: 90 minutes

    Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)

  5. Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)

    Time frame: 90 minutes

    TcPCO2 and SpO2 will be recorded by using a dedicated device (SenTec AG, Therwil, Switzerland)

  6. Dyspnea score

    Time frame: 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

  7. Comfort

    Time frame: immediately after intervention

    this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: CODUET

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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