Pneumonia, Bacterial, Respiratory Failure, COVID-19 Pneumonia
Conditions
Brief 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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTArterial 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_TESTRespiratory rate (RR)
Measurement of respiratory rate by waveform analysis using a ventilator
DIAGNOSTIC_TESTPulseoximeter
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
DIAGNOSTIC_TESTAssessment 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_TESTEsophageal pressure measurement
Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure
DIAGNOSTIC_TESTDiscomfort Visual Analog Scale (VAS)
From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.
DIAGNOSTIC_TESTNoninvasive blood pressure
Noninvasive blood pressure
DIAGNOSTIC_TESTHeart rate
Heart rate calculation using electrocardiogram monitoring
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Enrolled patients will receive all types of respiratory support (helmet CPAP 40 minutes followed by full face mask CPAP 40 minutes or full face mask CPAP 40 minutes followed by helmet CPAP 40 minutes) in a randomized crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory effort | 40 minutes | Delta esophageal pressure |
| Inspiratory delta transpulmonary pressure (stress) | 40 minutes | Inspiratory delta transpulmonary pressure |
| Expiratory delta transpulmonary pressure | 40 minutes | Expiratory delta transpulmonary pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patrick's score | 40 minutes | Patrick's score measurement, minimum 1point, maximum 5 points, higher score means worse outcome. 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. |
| Discomfort visual analog scale (VAS) | 40 minutes | Discomfort VAS score calculation, minimum 1point, maximum 10 points, higher score means better outcome |
| Oxygenation | 40 minutes | PaO2/FiO2 calculation |
| Heart rate | 40 minutes | Heart rate calculation using electrocardiogram monitoring |
| Noninvasive blood pressure | 40 minutes | Noninvasive blood pressure |
| Respiratory rate | 40 minutes | Measurement of respiratory rate by waveform analysis using a ventilator |
| ROX index | 40 minutes | Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR) |
Countries
Russia
Outcome results
None listed