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

NCT ID: NCT05528289

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2023-10-30

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HFNC 40 L/min with conventional symmetric nasal cannula

The patients will be asked to breathe with HFNC at flow of 40 L/min with standard interface

Group Type ACTIVE_COMPARATOR

AIRVO 2, the new asymmetric nasal cannula

Intervention Type 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%.

HFNC 40 L/min with 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

Group Type ACTIVE_COMPARATOR

AIRVO 2, with conventional symmetric nasal cannula

Intervention Type 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%.

Interventions

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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%.

Intervention Type DEVICE

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%.

Intervention Type DEVICE

Other Intervention Names

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standard cannula "Optiflow+ Duet"

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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dr. Stefano Nava

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico di Sant'Orsola

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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n° 174/2022/Disp/AOUBo

Identifier Type: -

Identifier Source: org_study_id

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