- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759457
High Flow Nasal Cannula and Hypercapnia
High Flow Nasal Cannula (HFNC) in COPD Patients With Persistent Hypercapnia After an Acute Exacerbation
Study Overview
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: lara pisani, md
- Phone Number: 390516363253
- Email: lara.pisani@aosp.bo.it
Study Locations
-
-
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Bologna, Italy, 40138
- Recruiting
- Sant'Orsola Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Flow Nasal Cannula
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in Arterial Blood Gases (ABGs)
Time Frame: immediately after intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tolerance to the treatment
Time Frame: immediately after intervention
|
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
|
immediately after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: stefano nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Iperpneumo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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