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Completed

NCT Number: NCT04241861

High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure

The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

About this study

Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..

Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.

Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.

Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and >200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.

Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.

At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.

Patients will be considered eligible whether all the following inclusion criteria are met:

  • Respiratory rate>25 bpm.
  • PaO2/FiO2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°C, FiO2 set to achieve a SpO2 >92% and <98%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
  • PaCO2 <45mmHg
  • Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.
  • Written informed consent

Exclusion criteria

  • Exacerbation of asthma or chronic obstructive pulmonary disease;
  • Cardiogenic pulmonary oedema;
  • Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed Shock
  • Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia);
  • Glasgow coma scale <13;
  • Recent head surgery or anatomy that prevent the application of helmet or nasal cannula to patient's face.

Treatment and study plan

Respiratory support (High-flow oxygen therapy)

Other

Noninvasive respiratory support respiratory support

Respiratory support (Helmet PSV)

Other

Noninvasive respiratory support respiratory support

Respiratory support (Helmet CPAP)

Other

Noninvasive respiratory support respiratory support

Primary outcomes

  1. Inspiratory effort

    Time frame: 40 minutes

    The negative deflection in esophageal pressure during inspiration

  2. Tidal volume

    Time frame: 40 minutes

    The tidal change in lung impedance, assessed by electrical impedance tomography

Secondary outcomes

  1. Oxygenation

    Time frame: 40 minutes

    Ratio of PaO2 to FiO2

  2. Tidal volume distribution

    Time frame: 40 minutes

    Distribution of tidal volume within the lung regions, assessed by electrical impedance tomography

  3. Carbon dioxide

    Time frame: 40 minutes

    Blood carbon dioxide, measured with the arterial blood gas analysis

  4. Respiratory rate

    Time frame: 40 minutes

    Respiratory rate/minute, assessed with the esophageal pressure

  5. Dyspnea

    Time frame: 40 minutes

    Dyspnea assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of dyspnea

  6. Comfort

    Time frame: 40 minutes

    Comfort assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of discomfort

  7. Global impedance-derived End-expiratory lung volume

    Time frame: 40 minutes

    End-expiratory lung volume, measured with electrical impedance tomography

  8. Regional impedance-derived End-expiratory lung volume

    Time frame: 40 minutes

    End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography

  9. Dynamic transpulmonary driving pressure

    Time frame: 40 minutes

    The tidal change in transpulmonary pressure

  10. Global impedance-derived lung dynamic strain

    Time frame: 40 minutes

    Change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography

  11. Regional impedance-derived lung dynamic strain

    Time frame: 40 minutes

    Change in impedance due to tidal volume / end expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography

  12. Respiratory system dynamic compliance

    Time frame: 40 minutes

    Ratio of the tidal change in lung impedance to dynamic transpulmonary driving pressure

  13. Pendelluft

    Time frame: 40 minutes

    Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration

  14. Work of breathing

    Time frame: 40 minutes

    Esophageal pressure simplified pressure time product per minute

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Registry information

Official study title

Physiological Comparison of High-flow Nasal Cannula, Helmet Pressure Support Ventilation and Continuous Positive Airway Pressure During Acute Hypoxemic Respiratory Failure: a Randomized Cross-over Study

Acronym: HIGHFLOWHELMET

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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