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

Not Applicable

Completed

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

• Registration Number: NCT06113432
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study Start: 2023-09-19
• Status Verified: 2023-10
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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