High-flow Air Via Nasal Cannula vs Non-invasive Continuous Positive Airway Pressure for Hypercapnic Respiratory Failure

NCT03944525 | Unknown

• 1 other identifier: 1352/2017
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be performed as a randomized controlled non-inferiority trial. HFA has been increasingly used in the last years to treat hypoxic respiratory failure (i.e. type I failure), and numerous studies have shown its efficiency in this indication. Despite this good evidence for HFA in hypoxic respiratory failure, it has only reluctantly been used for hypercapnic respiratory failure. HFA has been shown to generate PEEP, despite not being a closed system, and to improve CO2 clearance by flushing anatomical dead space. It might also help to reduce inspiratory resistance and facilitate secretion clearance from humidified gas. A study on COPD patients showed an increase in breathing pressure amplitude and mean pressure, as well as tidal volume, with a trend towards reduction of carbon dioxide partial pressure. Intervention consists of HFA using standard equipment at the department. A gas flow of 60 litres per minute and a FiO2 as clinically feasible will be used. Therapy will be continued until a pCO2-level of 50 mmHg or less is reached, or therapy has to be aborted because of lack of tolerance by the patient or indication for intubation. Control consists of non-invasive continuous positive airway pressure ventilation support using a tight mask and standard respirator equipment of the Department of Emergency Medicine. A positive airway pressure of 3,67 mmHg and a FiO2 as clinically feasible will be used. Therapy will be continued until a pCO2-level of 50 mmHg or less is reached, or therapy has to be aborted because of lack of tolerance by the patient or indication for intubation.

Conditions

Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Change of pCO2 in arterial blood gas

  The investigators assume baseline pCO2-levels of 50 to 100 mmHg in arterial blood gas, measured every 60 minutes.

  first 24 hours

Secondary Outcomes (10)

• Frequency of therapy failure

  first 24 hours

• Patient's perception of the therapy

  first 24 hours

• Rate of adverse events

  first 24 hours

• Time until pCO2 reaches 50mmHg or less

  first 24 hours

• Length of Stay at the Emergency Department

  first 24 hours

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Intervention consists of HFA using standard equipment at the department. A gas flow of 60L/min and a FiO2 as clinically feasible will be used. Therapy will be continued until a pCO2-level of 50mmHg or less is reached, or therapy has to be aborted because of lack of tolerance by the pati ent or indication for intubation.

Device: High flow nasal cannula

Control

ACTIVE COMPARATOR

Control consists of non-invasive CPAP ventilation support using a tight mask and standard respirator equipment of the Department of Emergency Medicine. A positive airway pressure of 5cm H2O and a FiO2 as clinically feasible will be used. Therapy will be continued until a pCO2-level of 50mmHg or less is reached, or therapy has to be aborted because of lack of tolerance by the patient or indication for intubation.

Device: Continuous positive airway pressure

Interventions

High flow nasal cannula DEVICE

Oxygen-therapy via HFNC

Intervention

Continuous positive airway pressure DEVICE

Non-invasive CPAP ventilation

Control

Eligibility Criteria

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

You may qualify if:

• Adult patients (e.g. at least 18 years old) treated at the Emergency Department
• Acute hypercapnic respiratory failure defined as a pCO2 \>50mmHg and a pH\<7.30 on admission

You may not qualify if:

• Patients being comatose on admission, with no intact airway, lack of airway-protective reflexes, or those who are not alert enough to follow commands
• Patients intubated by Emergency Medical Service
• Patients requiring intubation on admission
• Pregnant women

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1180, Austria

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

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: Dr.

Model Details: The study will be performed as a randomized controlled non-inferiority trial. The study site is the Department of Emergency Medicine (ED) at the Vienna General Hospital, a leading academic research center for emergency medicine at a large, tertiary care hospital. Around 90,000 patients are being treated at the department each year, approximately 150-200 of them suffering from hypercapnic respiratory failure, and requiring non-invasive ventilation support. The department features its own ICU and intermediate-care unit, with 7 positions each, for a total of 14 positions capable of providing CPAP therapy. The HFA-device is also at regular use at the department.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 9, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)