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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Device: AIRVO 2, with conventional symmetric nasal cannula
Device: AIRVO 2, the new asymmetric nasal cannula

Study type

Interventional

Funder types

Other

Identifiers

NCT05528289
n° 174/2022/Disp/AOUBo

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

HFNC 40 L/min with conventional symmetric nasal cannula
Active Comparator group
Description:
The patients will be asked to breathe with HFNC at flow of 40 L/min with standard interface
Treatment:
Device: AIRVO 2, the new asymmetric nasal cannula
HFNC 40 L/min with new asymmetric nasal cannula
Active Comparator group
Description:
The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula
Treatment:
Device: AIRVO 2, with conventional symmetric nasal cannula

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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