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High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation

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ClinicalTrials.gov Identifier: NCT03370666
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera Policlinico "Mater Domini"
Information provided by (Responsible Party):
Andrea Cortegiani, MD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Other: HFNT Other: NIV Not Applicable

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 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 charge decide to interrupt HFNT and start NIV because the patient shows signs of persisting worsening respiratory failure; 2) physician in charge decide to interrupt HFNT and perform endotracheal intubation and invasive mechanical ventilation because patient shows one or more of these conditions: respiratory arrest, respiratory pauses with loss of consciousness, psychomotor agitation making nursing care impossible, heart rate < 50 with loss of alertness, hemodynamic instability with systolic arterial blood pressure <70 mmHg, development of conditions requiring intubation either to protect the airway or to manage copious tracheal secretions, inability to tolerate the devices; 3) clinical improvement defined as all these conditions: normal mental status, hemodynamic stability, respiratory rate below 25 per minute, absence of activation of accessory respiratory muscles and paradoxical abdominal motion, no dyspnea arterial pH > 7.35, Arterial partial pressure of carbon dioxide (PaCO2) < 70 mmHg and Arterial partial pressure of oxygen (PaO2) > 55 mmHg with an inspired oxygen fraction (FiO2) < 0.35.

In case of temporary interruption of the intervention for any cause, patients should receive oxygen supplementation with Venturi mask with a target of SpO2 88-92%.The comparator will be non invasive ventilation (NIV). NIV must be delivered by full or oronasal mask. 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.

The intervention will last until one of the following conditions: 1) physician in charge decide to interrupt NIV and perform endotracheal intubation and invasive mechanical ventilation because patient shows one or more of these conditions: respiratory arrest, respiratory pauses with loss of consciousness, psychomotor agitation making nursing care impossible, heart rate < 50 with loss of alertness, hemodynamic instability with systolic arterial blood pressure <70 mmHg, development of conditions requiring intubation either to protect the airway or to manage copious tracheal secretions, inability to tolerate the devices; 2) clinical improvement defined as all these conditions: normal mental status, hemodynamic stability, respiratory rate below 25 per minute, absence of activation of accessory respiratory muscles and paradoxical abdominal motion, no dyspnoea arterial pH > 7.35, Arterial partial pressure of carbon dioxide (PaCO2) < 70 mmHg and Arterial partial pressure of oxygen (PaO2) > 55 mmHg with an inspired oxygen fraction (FiO2) < 0.35.

In case of temporary interruption of NIV for any cause, patients should receive oxygen supplementation with Venturi mask with a target of SpO2 88-92%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Nasal Therapy Versus Noninvasive Ventilation in Mild to Moderate Acute Hypercapnic Respiratory Failure: A Non-inferiority Randomized Trial
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : March 25, 2020
Actual Study Completion Date : April 15, 2020

Arm Intervention/treatment
Experimental: HFNT
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
High flow nasal therapy

Active Comparator: NIV
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
Noninvasive ventilation




Primary Outcome Measures :
  1. Arterial partial pressure of carbon dioxide (PaCO2) [ Time Frame: 2 hours after randomization ]

Secondary Outcome Measures :
  1. Dyspnea evaluated with Borg dyspnea scale [ Time Frame: 2 and 6 hours after randomization ]
    Borg dyspnea scale: this is a 12-point validated scale that rates patient's difficulty in breathing. It starts at number 0 where breathing causes no difficulty at all and progresses through number 10 where breathing difficulty is maximal

  2. Arterial partial pressure of carbon dioxide (PaCO2) [ Time Frame: 6 hours after randomization ]

Other Outcome Measures:
  1. Respiratory rate [ Time Frame: 2 and 6 hours after randomization ]
  2. Discontinuation of the interventions [ Time Frame: At 6 hours after randomization ]
    The inability of the patient to continue the treatment while there was still an indication for ventilatory support

  3. Overall discomfort related to the interface [ Time Frame: At 6 hours after randomization ]
  4. Presence of side effects [ Time Frame: At 6 hours after randomization ]
    I.e., complaining for noise or too high temperature of flow, claustrophobia, gastric distension, vomiting, sweating, tightness

  5. Rate of treatment failure [ Time Frame: At 6 hours after randomization ]
    defined as the presence of one or more of the following: arterial partial pressure of carbon dioxide (PaCO2) reduction, no change or reduction < 10 mmHg from baseline, worsening or no improvement in dyspnoea, respiratory rate > 30 breaths per minute, use of accessory respiratory muscles or paradoxical abdominal movement

  6. Rate of endotracheal intubation [ Time Frame: At 6 hours after randomization ]
    Number of patients requiring endotracheal intubation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370666


Locations
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Italy
Ospedale S. Donato
Arezzo, Italy
Ospedale Sant'Orsola Malpighi. Università Alma Mater
Bologna, Italy
A.O.U. Policlinico-Vittorio Emanuele, Università degli Studi di Catania
Catania, Italy
Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, Italy
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
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo
Palermo, Italy
IRCCS Maugeri
Pavia, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Ospedale Molinette
Torino, Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, Italy
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Azienda Ospedaliera Policlinico "Mater Domini"
Investigators
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Study Director: Paolo Navalesi, MD Azienda Ospedaliera Policlinico "Mater Domini"
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Cortegiani, MD, Principal Investigator, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
ClinicalTrials.gov Identifier: NCT03370666    
Other Study ID Numbers: 07/17
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases