Status:
COMPLETED
High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation
Lead Sponsor:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Collaborating Sponsors:
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Conditions:
COPD Exacerbation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized multicenter non-inferiority trial comparing High flow nasal therapy (HFNT) versus Noninvasive ventilation (NIV) in patients with chronic obstructive pulmonary disease (COPD) and acute hyper...
Detailed Description
The interventions will be delivered in Emergency Departments or Intensive Care Units. The intervention under investigation will be High flow nasal therapy. Investigators will deliver HFNT to enrolled...
Eligibility Criteria
Inclusion
- Presence of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure;
- 25 \< pH \< 7.35;
- Arterial Partial pressure of carbon dioxide (PaCO2) equal or greater than 55 mmHg;
- Age \> 18 years/old
Exclusion
- Invasive mechanical ventilation in the last 60 days
- Use of any form of noninvasive ventilation or high flow oxygen through nasal cannula (HFNT) prior to study enrollment after the onset of acute hypercapnic respiratory failure (AHRF);
- Noninvasive home care ventilation;
- Unstable clinical condition (need for vasopressors for \>24 h, acute coronary syndrome or life-threatening arrhythmias);
- Refusal of treatment;
- Agitation (RASS \>= +2) or non-cooperation (Kelly Matthay \>=5);
- Failure of more than two organs;
- Cardiac arrest;
- Respiratory arrest requiring tracheal intubation;
- Recent trauma or burns of the neck and face;
- Pregnancy;
- Refusal of consent;
- Inclusion in other research protocols.
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03370666
Start Date
February 15 2018
End Date
April 15 2020
Last Update
April 30 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale S. Donato
Arezzo, Italy
2
Ospedale Sant'Orsola Malpighi. Università Alma Mater
Bologna, Italy
3
A.O.U. Policlinico-Vittorio Emanuele, Università degli Studi di Catania
Catania, Italy
4
Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, Italy