Clinical trial NCT06113432: CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Bacterial
Respiratory Failure
COVID-19 Pneumonia
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inspiratory effort
timeFrame: 40 minutes
measure: Inspiratory delta transpulmonary pressure (stress)
timeFrame: 40 minutes
measure: Expiratory delta transpulmonary pressure
timeFrame: 40 minutes
Secondary outcomes:
measure: Oxygenation
timeFrame: 40 minutes
measure: Respiratory rate
timeFrame: 40 minutes
measure: ROX index
timeFrame: 40 minutes
measure: Patrick's score
timeFrame: 40 minutes
measure: Discomfort visual analog scale (VAS)
timeFrame: 40 minutes
measure: Noninvasive blood pressure
timeFrame: 40 minutes
measure: Heart rate
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City clinical hospital named after F.I.Inozemtsev, Moscow
Study officials:
affiliation: Sechenov University
name: Andrey I Yaroshetskiy, MD, PhD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Care Med. 2002 Mar;30(3):602-8. doi: 10.1097/00003246-200203000-00019.
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 Aug 28.
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.
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: 10.1007/s00134-003-1825-9. Epub 2003 Jun 12.
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/S0375-9393.19.13418-9. Epub 2019 Mar 12.
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-journals-10071-24155.
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 Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.