High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation

NCT03370666 | Completed

• 1 other identifier: 07/17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

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 hypercapnic respiratory failure.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Arterial partial pressure of carbon dioxide (PaCO2)

  2 hours after randomization

Secondary Outcomes (2)

• Dyspnea evaluated with Borg dyspnea scale

  2 and 6 hours after randomization

• Arterial partial pressure of carbon dioxide (PaCO2)

  6 hours after randomization

Other Outcomes (6)

• Respiratory rate

  2 and 6 hours after randomization

• Discontinuation of the interventions

  At 6 hours after randomization

• Overall discomfort related to the interface

  At 6 hours after randomization

Study Arms (2)

HFNT

EXPERIMENTAL

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.

Other: HFNT

NIV

ACTIVE COMPARATOR

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.

Other: NIV

Interventions

HFNT OTHER

High flow nasal therapy

HFNT

NIV OTHER

Noninvasive ventilation

NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure;
• \< pH \< 7.35;
• Arterial Partial pressure of carbon dioxide (PaCO2) equal or greater than 55 mmHg;
• Age \> 18 years/old

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead
• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: collaborator

Study Sites (10)

Ospedale S. Donato

Arezzo, Italy

Location

Ospedale Sant'Orsola Malpighi. Università Alma Mater

Bologna, Italy

Location

A.O.U. Policlinico-Vittorio Emanuele, Università degli Studi di Catania

Catania, Italy

Location

Azienda Ospedaliera Universitaria Mater Domini

Catanzaro, Italy

Location

University Hospital of Modena, Pneumology Unit and Center for Rare Lung Diseases, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia

Modena, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo

Palermo, Italy

Location

IRCCS Maugeri

Pavia, Italy

Location

Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Ospedale Molinette

Torino, Italy

Location

Azienda Sanitaria Universitaria Integrata di Udine

Udine, Italy

Location

Related Publications (2)

• Cortegiani A, Longhini F, Madotto F, Groff P, Scala R, Crimi C, Carlucci A, Bruni A, Garofalo E, Raineri SM, Tonelli R, Comellini V, Lupia E, Vetrugno L, Clini E, Giarratano A, Nava S, Navalesi P, Gregoretti C; H. F.-AECOPD study investigators. High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial. Crit Care. 2020 Dec 14;24(1):692. doi: 10.1186/s13054-020-03409-0.

  PMID: 33317579 DERIVED

• Cortegiani A, Longhini F, Carlucci A, Scala R, Groff P, Bruni A, Garofalo E, Taliani MR, Maccari U, Vetrugno L, Lupia E, Misseri G, Comellini V, Giarratano A, Nava S, Navalesi P, Gregoretti C. High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial. Trials. 2019 Jul 22;20(1):450. doi: 10.1186/s13063-019-3514-1.

  PMID: 31331372 DERIVED

Study Officials

• Paolo Navalesi, MD

  Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-inferiority

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: February 15, 2018
• Primary Completion: March 25, 2020
• Study Completion: April 15, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

IT (10)