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

Respiratory Failure Clinical Trial

— HIGHFLOWHELMET  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241861
• Other study ID #: 2693
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: January 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Respiratory rate>25 bpm.

2. 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.

3. PaCO2 <45mmHg

4. Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.

5. 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.

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Respiratory support (High-flow oxygen therapy)
Noninvasive respiratory support respiratory support
• Respiratory support (Helmet PSV)
Noninvasive respiratory support respiratory support
• Respiratory support (Helmet CPAP)
Noninvasive respiratory support respiratory support

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitaro A. Gemelli IRCCS	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Società Italiana di Anestesia, Analgesia, Rianimazione e Terapia Intensiva

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory effort	The negative deflection in esophageal pressure during inspiration	40 minutes
Primary	Tidal volume	The tidal change in lung impedance, assessed by electrical impedance tomography	40 minutes
Secondary	Oxygenation	Ratio of PaO2 to FiO2	40 minutes
Secondary	Tidal volume distribution	Distribution of tidal volume within the lung regions, assessed by electrical impedance tomography	40 minutes
Secondary	Carbon dioxide	Blood carbon dioxide, measured with the arterial blood gas analysis	40 minutes
Secondary	Respiratory rate	Respiratory rate/minute, assessed with the esophageal pressure	40 minutes
Secondary	Dyspnea	Dyspnea assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of dyspnea	40 minutes
Secondary	Comfort	Comfort assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of discomfort	40 minutes
Secondary	Global impedance-derived End-expiratory lung volume	End-expiratory lung volume, measured with electrical impedance tomography	40 minutes
Secondary	Regional impedance-derived End-expiratory lung volume	End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography	40 minutes
Secondary	Dynamic transpulmonary driving pressure	The tidal change in transpulmonary pressure	40 minutes
Secondary	Global impedance-derived lung dynamic strain	Change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography	40 minutes
Secondary	Regional impedance-derived lung dynamic strain	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	40 minutes
Secondary	Respiratory system dynamic compliance	Ratio of the tidal change in lung impedance to dynamic transpulmonary driving pressure	40 minutes
Secondary	Pendelluft	Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration	40 minutes
Secondary	Work of breathing	Esophageal pressure simplified pressure time product per minute	40 minutes