High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation
COPD Exacerbation
About this trial
This is an interventional treatment trial for COPD Exacerbation
Eligibility Criteria
Inclusion Criteria:
- Presence of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure;
- 7.25 < pH < 7.35;
- Arterial Partial pressure of carbon dioxide (PaCO2) equal or greater than 55 mmHg;
- Age > 18 years/old
Exclusion Criteria:
- 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.
Sites / Locations
- Ospedale S. Donato
- Ospedale Sant'Orsola Malpighi. Università Alma Mater
- A.O.U. Policlinico-Vittorio Emanuele, Università degli Studi di Catania
- Azienda Ospedaliera Universitaria Mater Domini
- University Hospital of Modena, Pneumology Unit and Center for Rare Lung Diseases, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo
- IRCCS Maugeri
- Azienda Ospedaliera di Perugia
- Ospedale Molinette
- Azienda Sanitaria Universitaria Integrata di Udine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
HFNT
NIV
HFNT performed with any available device. The flow will be initially set at 60 liters per minute and temperature at 37° C. The target will be an oxygen saturation (SpO2) of 88-92%. In case of patient not tolerating these settings, flow and temperature will be titrated to the maximum tolerated level.
NIV must be delivered by full or oronasal mask with any available ventilator. The ventilator settings will be decided according to the usual practice: maximal tolerated inspiratory pressure to obtain a measured or estimated expired tidal volume of 6-8 mL·kg-1 of body weight and a positive end expiratory pressure (PEEP) between 3 and 5 cmH2O. An interface rotational strategy will be allowed among only different types of masks.