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

Summary

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.

Conditions

• Pneumonia, Bacterial
• Respiratory Failure
• COVID-19 Pneumonia

Interventions

DIAGNOSTIC_TEST

Arterial blood gases

Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio

DIAGNOSTIC_TEST

Respiratory rate (RR)

Measurement of respiratory rate by waveform analysis using a ventilator

DIAGNOSTIC_TEST

Pulseoximeter

Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)

DIAGNOSTIC_TEST

Assessment of accessory respiratory muscles work

Patrick score calculation. Score: 0. No visible tonic or phasic use of neck muscles. 1. Neck muscles taut but with no respiratory modulation (i.e., tonic activity). 2. Mild respiratory modulation in neck muscle contraction. 3. Moderate phasic activity (no supraclavicular or intercostal indrawing). 4. Vigorous phasic activity with indrawing. 5. Vigorous phasic activity with abdominal paradox.

DIAGNOSTIC_TEST

Esophageal pressure measurement

Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure

DIAGNOSTIC_TEST

Discomfort Visual Analog Scale (VAS)

From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.

DIAGNOSTIC_TEST

Noninvasive blood pressure

Noninvasive blood pressure

DIAGNOSTIC_TEST

Heart rate

Heart rate calculation using electrocardiogram monitoring

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University

  lead OTHER

Principal Investigators

• Andrey I Yaroshetskiy, MD, PhD, ScD · Sechenov University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-19

Primary Completion

2024-05-30

Completion

2024-05-30

Countries

• Russia

Study Locations