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Search / Trial NCT03370666

High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE PALERMO · Dec 7, 2017

Trial Information

Current as of June 20, 2025

Completed

Keywords

ClinConnect Summary

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 patients using any available device able to produce it. 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. The intervention will last until one of the following conditions: 1) physician in...

Gender

ALL

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.

About Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo is a leading academic hospital located in Palermo, Italy, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, it integrates cutting-edge medical research with comprehensive patient care, fostering collaborations among healthcare professionals, researchers, and academic institutions. The organization is committed to enhancing medical knowledge and improving patient outcomes through rigorous clinical trials, adhering to the highest ethical standards and regulatory requirements. Its multidisciplinary approach ensures a robust framework for conducting research that addresses critical health challenges while prioritizing patient safety and welfare.

Locations

Perugia, , Italy

Torino, , Italy

Arezzo, , Italy

Udine, , Italy

Bologna, , Italy

Catania, , Italy

Catanzaro, , Italy

Modena, , Italy

Palermo, , Italy

Pavia, , Italy

Patients applied

0 patients applied

Trial Officials

Paolo Navalesi, MD

Study Director

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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