High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2020-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure

NCT03311087

Acute Respiratory Failure With Hypoxia Hypoxemia

UNKNOWN

NHF vs NIV in Patients With Acute Exacerbation of COPD

NCT03466385

Chronic Obstructive Pulmonary Disease Respiratory Failure Acute Exacerbation Copd

UNKNOWN NA

Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis

NCT06114667

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Hypercapnic Acidosis Respiratory Failure With Hypercapnia

NOT_YET_RECRUITING NA

Efficacy of High Velocity Nasal Insufflation

NCT03929055

Acute Respiratory Failure Diaphragmatic Function Esophageal Pressure

UNKNOWN NA

Comparison of High-flow Oxygen vs. BiPAP in Type II (Hypercapnic) Respiratory Failure

NCT03443479

Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases +4 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

HFNT

Intervention Type OTHER

High flow nasal therapy

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.

Group Type ACTIVE_COMPARATOR

NIV

Intervention Type OTHER

Noninvasive ventilation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HFNT

High flow nasal therapy

Intervention Type OTHER

NIV

Noninvasive ventilation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No