High Flow Nasal Cannula and Hypercapnia

NCT03759457 | Unknown DMC

• 1 other identifier: Iperpneumo
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In the present investigation, in 50 COPD with persistent hypercapnia after an acute exacerbation, the investigators want to assess the acceptability of HFNC and its effectiveness in further reducing the level of PaCO2, and to eventually verify the hypothesis, based on previous physiological studies, that the response to HFNC is dependent on the level of baseline hypercapnia and eventually on the presence of overlap syndrome. This latter parameters to eventually calculate the sample size and the target population to perform future definitive randomized long term trials vs NIV.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• changes in Arterial Blood Gases (ABGs)

  Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery

  immediately after intervention

Secondary Outcomes (1)

• tolerance to the treatment

  immediately after intervention

Study Arms (1)

High Flow Nasal Cannula

EXPERIMENTAL

High Flow Nasal Cannula is a relatively new technique able to deliver both oxygen and high flow in order to improve oxygenation and waking out CO2 from the upper airways

Device: High Flow Nasal Cannula (AIRVO2)

Interventions

High Flow Nasal Cannula (AIRVO2) DEVICE

High-flow nasal cannula (HFNC) delivers oxygen flows of up to 60 L/min. The gas source (air/oxygen blender, ventilator, or turbine flow-generator) is connected via an active heated humidifier to a nasal cannula and allows FiO2 adjustment independently from the flow

High Flow Nasal Cannula

Eligibility Criteria

• Age: 18 Years - 85 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\>45 mmHg on 3 consecutive measurements)

You may not qualify if:

• Cardiac decompensation,
• restrictive thoracic disorders,
• renal insufficiency,
• cancer,
• neurological disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Sant'Orsola Hospital

Bologna, 40138, Italy

RECRUITING

Related Publications (1)

• Pisani L, Betti S, Biglia C, Fasano L, Catalanotti V, Prediletto I, Comellini V, Bacchi-Reggiani L, Fers SN. Effects of high-flow nasal cannula in patients with persistent hypercapnia after an acute COPD exacerbation: a prospective pilot study. BMC Pulm Med. 2020 Jan 13;20(1):12. doi: 10.1186/s12890-020-1048-7.

  PMID: 31931776 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• stefano nava

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lara pisani, md

CONTACT

390516363253; lara.pisani@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Respiratory nad Critical Care Unit

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: November 29, 2018
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)