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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113432
• Other study ID #: Helmet-Mask-ARF
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Andrey I Yaroshetskiy, MD, PhD, ScD
• Phone: +79859900148
• Email: dr.intensivist[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• Respiratory rate (RR)
Measurement of respiratory rate by waveform analysis using a ventilator
• Pulseoximeter
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
• 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.
• Esophageal pressure measurement
Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure
• Discomfort Visual Analog Scale (VAS)
From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.
• Noninvasive blood pressure
Noninvasive blood pressure
• Heart rate
Heart rate calculation using electrocardiogram monitoring

Locations

Country	Name	City	State
Russian Federation	City clinical hospital named after F.I.Inozemtsev, Moscow	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (7)

Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial. Crit Ca — View Citation

Chiumello D, Pelosi P, Carlesso E, Severgnini P, Aspesi M, Gamberoni C, Antonelli M, Conti G, Chiaranda M, Gattinoni L. Noninvasive positive pressure ventilation delivered by helmet vs. standard face mask. Intensive Care Med. 2003 Oct;29(10):1671-9. doi: — View Citation

Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.134 — View Citation

Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive V — View Citation

Patroniti N, Foti G, Manfio A, Coppo A, Bellani G, Pesenti A. Head helmet versus face mask for non-invasive continuous positive airway pressure: a physiological study. Intensive Care Med. 2003 Oct;29(10):1680-7. doi: 10.1007/s00134-003-1931-8. Epub 2003 A — View Citation

Saxena A, Nazir N, Pandey R, Gupta S. Comparison of Effect of Non-invasive Ventilation Delivered by Helmet vs Face Mask in Patients with COVID-19 Infection: A Randomized Control Study. Indian J Crit Care Med. 2022 Mar;26(3):282-287. doi: 10.5005/jp-journa — View Citation

Vargas F, Thille A, Lyazidi A, Campo FR, Brochard L. Helmet with specific settings versus facemask for noninvasive ventilation. Crit Care Med. 2009 Jun;37(6):1921-8. doi: 10.1097/CCM.0b013e31819fff93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory effort	Delta esophageal pressure	40 minutes
Primary	Inspiratory delta transpulmonary pressure (stress)	Inspiratory delta transpulmonary pressure	40 minutes
Primary	Expiratory delta transpulmonary pressure	Expiratory delta transpulmonary pressure	40 minutes
Secondary	Oxygenation	PaO2/FiO2 calculation	40 minutes
Secondary	Respiratory rate	Measurement of respiratory rate by waveform analysis using a ventilator	40 minutes
Secondary	ROX index	Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)	40 minutes
Secondary	Patrick's score	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.	40 minutes
Secondary	Discomfort visual analog scale (VAS)	Discomfort VAS score calculation, minimum 1point, maximum 10 points, higher score means better outcome	40 minutes
Secondary	Noninvasive blood pressure	Noninvasive blood pressure	40 minutes
Secondary	Heart rate	Heart rate calculation using electrocardiogram monitoring	40 minutes