Status:
UNKNOWN
NHF vs NIV in Patients With Acute Exacerbation of COPD
Lead Sponsor:
Evangelismos Hospital
Collaborating Sponsors:
Venizeleio General Hospital, Heraklion, Crete
Larissa University Hospital
Conditions:
Chronic Obstructive Pulmonary Disease
Respiratory Failure
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
Although non-invasive ventilation (NIV) usage has increased significantly over time in COPD exacerbation, a great percentage of patients (\~30%) present contraindications to NIV or cannot tolerate it....
Detailed Description
The use of non-invasive ventilation (NIV) in COPD exacerbation has increased significantly over time since it has been shown to improve acute respiratory acidosis (increases pH and decreases PaCO2), d...
Eligibility Criteria
Inclusion
- Patient with mild to moderate COPD exacerbation and the following characteristics persisting after initial medical therapy with bronchodilators and controlled oxygen therapy
- 7,25\<pH\<7,35
- PaCO2\>45mmHg
- RR\>23
- Ability to obtain written informed consent by the patient or patient's next of kin
Exclusion
- severe facial deformity
- Facial burns
- Fixed upper airway obstruction
- Criteria for imminent intubation and invasive mechanical ventilation (any of the following)
- respiratory or cardiac arrest
- gasping respiration
- pH \<7.15
- depressed consciousness (Glasgow Coma Score \<8)
- psychomotor agitation inadequately controlled by sedation
- massive aspiration
- persistent inability to remove respiratory secretions
- heart rate \< 50 ·min-1 with loss of alertness
- severe hemodynamic instability without response to fluids and vasoactive drugs
- severe ventricular arrhythmias
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT03466385
Start Date
April 15 2018
End Date
December 31 2021
Last Update
February 20 2020
Active Locations (3)
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1
Venizeleio Hospital
Heraklion, Crete, Greece, 71409
2
Evangelismos Hospital
Athens, Greece, 10673
3
University General Hospital of Larisa
Larissa, Greece, 41110