High Flow Nasal Cannula and Hypercapnia
Primary Purpose
COPD
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Flow Nasal Cannula (AIRVO2)
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
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>45 mmHg on 3 consecutive measurements)
Exclusion Criteria:
- Cardiac decompensation,
- restrictive thoracic disorders,
- renal insufficiency,
- cancer,
- neurological disease
Sites / Locations
- Sant'Orsola HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Flow Nasal Cannula
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
tolerance to the treatment
this will be assessed using a standardized 4 points scale where tolerance to the treatment as reported by the patient, where categorized as: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good
Full Information
NCT ID
NCT03759457
First Posted
November 28, 2018
Last Updated
November 29, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03759457
Brief Title
High Flow Nasal Cannula and Hypercapnia
Official Title
High Flow Nasal Cannula (HFNC) in COPD Patients With Persistent Hypercapnia After an Acute Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
January 29, 2019 (Anticipated)
Study Completion Date
January 29, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Fifthy COPD patients inpatients recovering from an acute exacerbation of their disease and persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH>7,35 and PaCO2>45 mmHg on 3 consecutive measurements) will be enrolled in the study after having signed a written informed consent OSA/COPD overlap syndrome was not considered and exclusion criteria and is defined as the presence of 15 or more obstructive respiratory events per hour of sleep, when a previous full night polysomnography (PSG) was available or from a positive Epworth questionnaire and a Body Mass Index>25 Cardiac decompensation, restrictive thoracic disorders, renal insufficiency, cancer, and neurological disease were considered exclusion criteria.
On day the patients will undergo a preliminary trial with HFNC to set the optimal flow, using the AIRVO2 (Fisher & Paykel Healthcare, Auckland, New Zealand). To this aim the patients will be asked to breathe keeping their mouth closed, as much as they could, at different levels of flow, starting from 20 L/min up to 40 if tolerated for a minimum of 15 minutes for each trial. At the end of this test the maximum level tolerated will be chosen as the flow to be set for the experimental procedure. Temperature will be set according to the patient's tolerance starting from 34C, up to 37C, while FiO2 will be kept constant to maintain an SaO2 between 92 and 94%.
From 9 am of day 2 to 9 am of day 5 (72 hours period), the patients will undergo HFNC for at least 8 hours/day and during the nightime. The nurse on shift will be in charge of supervising the adherence to this schedule and to report any violation of the protocol on a dedicated sheet. Every morning at 10 am (1 hour after HFNC suspension) Arterial Blood Gases (ABGs), effective hours of HFT and tolerance to the treatment as reported by the patient, using a dedicated scale where: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good) will be recorded
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Flow Nasal Cannula
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula (AIRVO2)
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in Arterial Blood Gases (ABGs)
Description
Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
tolerance to the treatment
Description
this will be assessed using a standardized 4 points scale where tolerance to the treatment as reported by the patient, where categorized as: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good
Time Frame
immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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>45 mmHg on 3 consecutive measurements)
Exclusion Criteria:
Cardiac decompensation,
restrictive thoracic disorders,
renal insufficiency,
cancer,
neurological disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lara pisani, md
Phone
390516363253
Email
lara.pisani@aosp.bo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano nava
Organizational Affiliation
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sant'Orsola Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, md
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
cannot release data prior to the termination of the study
Citations:
PubMed Identifier
31931776
Citation
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.
Results Reference
derived
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High Flow Nasal Cannula and Hypercapnia
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