CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: COVID-19 Pneumonia; Respiratory Failure; Pneumonia, Bacterial

Treatments: Diagnostic Test: Heart rate; Diagnostic Test: Noninvasive blood pressure; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Assessment of accessory respiratory muscles work; Diagnostic Test: Arterial blood gases; Diagnostic Test: Respiratory rate (RR); Diagnostic Test: Pulseoximeter; Diagnostic Test: Discomfort Visual Analog Scale (VAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06113432

Helmet-Mask-ARF

Details and patient eligibility

About

Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation. The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI), patient's comfort, work of breathing, gas exchange, and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.

Full description

In December 2019, an outbreak of a novel coronavirus emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of patients with predominant acute respiratory failure. Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation.

The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI) (measuring esophageal pressure, transpulmonary pressure during inspiration and expiration), the patient's work of breathing (assessment of accessory muscles work) patient's comfort by visual-analog scale, gas exchange (by PaO2/FiO2 and Respiration Oxygenation Index (ROX-index), and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive pulmonary ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia or COVID-19
• The ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
• Respiratory rate more than > 25 per minute.
• Written informed consent

Exclusion criteria

• Patients who achieve the following target parameters with only low-flow oxygen therapy (flow up to 15 l/min): SpO2 > 93%, the patient does not have a subjective feeling of fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
• Unstable hemodynamics (systolic blood pressure <90 mm Hg or mean arterial pressure <65 mm Hg) and/or lactic acidosis (lactate >5 mmol/l and/or clinically diagnosed shock) and/or life-threatening arrhythmia,
• Metabolic acidosis (pH <7.30);
• Patients who were in the ICU for less than 24 hours for any reason
• Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
• Cardiogenic pulmonary edema,
• Chronic diseases in the stag e of decompensation with the development of extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, CHF),
• Glasgow Coma Scale score <14 points,
• Swallowing disorders
• Hypercapnia (PaCO2>45 mmHg),
• The need for urgent tracheal intubation for any reason,
• Recent head surgery or anatomy that prevents the placement of a helmet or full face mask on the patient,
• Pregnancy,
• Inability to cooperate with staff

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Helmet-CPAP then Mask-CPAP

Experimental group

Description:

CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes

Treatment:

Diagnostic Test: Discomfort Visual Analog Scale (VAS)

Diagnostic Test: Pulseoximeter

Diagnostic Test: Respiratory rate (RR)

Diagnostic Test: Arterial blood gases

Diagnostic Test: Noninvasive blood pressure

Diagnostic Test: Esophageal pressure measurement

Diagnostic Test: Assessment of accessory respiratory muscles work

Diagnostic Test: Heart rate

Mask-CPAP then Helmet-CPAP

Experimental group

Description:

CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes

Treatment:

Diagnostic Test: Discomfort Visual Analog Scale (VAS)

Diagnostic Test: Pulseoximeter

Diagnostic Test: Respiratory rate (RR)

Diagnostic Test: Arterial blood gases

Diagnostic Test: Noninvasive blood pressure

Diagnostic Test: Esophageal pressure measurement

Diagnostic Test: Assessment of accessory respiratory muscles work

Diagnostic Test: Heart rate