CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
- Conditions
- Pneumonia, BacterialRespiratory FailureCOVID-19 Pneumonia
- Interventions
- Diagnostic Test: Arterial blood gasesDiagnostic Test: Respiratory rate (RR)Diagnostic Test: PulseoximeterDiagnostic Test: Assessment of accessory respiratory muscles workDiagnostic Test: Esophageal pressure measurementDiagnostic Test: Discomfort Visual Analog Scale (VAS)Diagnostic Test: Noninvasive blood pressureDiagnostic Test: Heart rate
- Registration Number
- NCT06113432
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Helmet-CPAP then Mask-CPAP Pulseoximeter CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Helmet-CPAP then Mask-CPAP Noninvasive blood pressure CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Helmet-CPAP then Mask-CPAP Discomfort Visual Analog Scale (VAS) CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Helmet-CPAP then Mask-CPAP Arterial blood gases CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Helmet-CPAP then Mask-CPAP Respiratory rate (RR) CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Helmet-CPAP then Mask-CPAP Heart rate CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Mask-CPAP then Helmet-CPAP Arterial blood gases CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Mask-CPAP then Helmet-CPAP Respiratory rate (RR) CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Helmet-CPAP then Mask-CPAP Esophageal pressure measurement CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Mask-CPAP then Helmet-CPAP Assessment of accessory respiratory muscles work CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Mask-CPAP then Helmet-CPAP Esophageal pressure measurement CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Mask-CPAP then Helmet-CPAP Noninvasive blood pressure CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Helmet-CPAP then Mask-CPAP Assessment of accessory respiratory muscles work CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Mask-CPAP then Helmet-CPAP Pulseoximeter CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Mask-CPAP then Helmet-CPAP Discomfort Visual Analog Scale (VAS) CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Mask-CPAP then Helmet-CPAP Heart rate CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes
- Primary Outcome Measures
Name Time Method Inspiratory delta transpulmonary pressure (stress) 40 minutes Inspiratory delta transpulmonary pressure
Inspiratory effort 40 minutes Delta esophageal pressure
Expiratory delta transpulmonary pressure 40 minutes Expiratory delta transpulmonary pressure
- Secondary Outcome Measures
Name Time Method 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)
Discomfort visual analog scale (VAS) 40 minutes Discomfort VAS score calculation, minimum 1point, maximum 10 points, higher score means better outcome
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.
Oxygenation 40 minutes PaO2/FiO2 calculation
Noninvasive blood pressure 40 minutes Noninvasive blood pressure
Heart rate 40 minutes Heart rate calculation using electrocardiogram monitoring
Trial Locations
- Locations (1)
City clinical hospital named after F.I.Inozemtsev, Moscow
🇷🇺Moscow, Russian Federation