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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Respiratory Failure; Hypoxemia

Treatments: Other: Respiratory support (High-flow oxygen therapy); Other: Respiratory support (Helmet CPAP); Other: Respiratory support (Helmet PSV)

Study type: Interventional

Funder types: Other

Identifiers

NCT04241861

2693

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

High-flow oxygen therapy

Experimental group

Description:

Nasal high flow oxygen therapy will be delivered with the Optiflow system. Initial set flow will be ≥ 50 /min and flows will be decreased in case of intolerance and/or according to patients' requirements: flows≥30 L/min will be mandatory in all enrolled patients. Humidification chamber (MR860, Fisher and Paykel healthcare, New Zealand) will be set at 37 °C or 34 °C according to patient's comfort33. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.

Treatment:

Other: Respiratory support (High-flow oxygen therapy)

Helmet PSV

Experimental group

Description:

Dedicated helmets for noninvasive ventilation will be used and size will be chosen according to neck circumference or according to manufacturer recommendations. Each patient will be connected to a compressed-gas based ventilator through a bitube circuit with no humidification. The ventilator will be set in PSV, with the following suggested settings 34-38: 1. initial pressure support≥8-10 cmH2O and adequate to permit of a peak in the inspiratory flow of 100 l/min; 2. positive end-expiratory pressure=10-12 cmH2O and increased to achieve the oxygenation target according to the choice of the attending physician. 3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. 4. Inspiratory flow trigger = 1 l/min or according to the practice of each institution; 5. fastest pressurization time; 6. expiratory trigger: 10-50% of the maximum inspiratory flow; 7. maximum inspiratory time 1.2 second.

Treatment:

Other: Respiratory support (Helmet PSV)

Helmet CPAP

Experimental group

Description:

Dedicated helmets for noninvasive ventilation will be uses and size will be chosen according to neck circumference or according to manufacturer recommendations. Treatment will be delivered through a high-flow generator. The following settings will be applied: 1. Continuous air flow=50-60 L/min. 2. Expiratory positive end-expiratory pressure valve set to achieve a PEEP==10-12 cmH2O and eventually increased to achieve the oxygenation target according to the choice of the attending physician. 3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Pressure inside the helmet will be monitored with a manometer in order to maintain the set PEEP.

Treatment:

Other: Respiratory support (Helmet CPAP)