Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
NCT Number: NCT04241861
The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure
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All sexes
Interventional
Not applicable
Rome, Italy
Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.
Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and >200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.
Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.
At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Patients will be considered eligible whether all the following inclusion criteria are met:
Exclusion criteria
Noninvasive respiratory support respiratory support
Noninvasive respiratory support respiratory support
Noninvasive respiratory support respiratory support
Time frame: 40 minutes
The negative deflection in esophageal pressure during inspiration
Time frame: 40 minutes
The tidal change in lung impedance, assessed by electrical impedance tomography
Time frame: 40 minutes
Ratio of PaO2 to FiO2
Time frame: 40 minutes
Distribution of tidal volume within the lung regions, assessed by electrical impedance tomography
Time frame: 40 minutes
Blood carbon dioxide, measured with the arterial blood gas analysis
Time frame: 40 minutes
Respiratory rate/minute, assessed with the esophageal pressure
Time frame: 40 minutes
Dyspnea assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of dyspnea
Time frame: 40 minutes
Comfort assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of discomfort
Time frame: 40 minutes
End-expiratory lung volume, measured with electrical impedance tomography
Time frame: 40 minutes
End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Time frame: 40 minutes
The tidal change in transpulmonary pressure
Time frame: 40 minutes
Change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography
Time frame: 40 minutes
Change in impedance due to tidal volume / end expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Time frame: 40 minutes
Ratio of the tidal change in lung impedance to dynamic transpulmonary driving pressure
Time frame: 40 minutes
Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration
Time frame: 40 minutes
Esophageal pressure simplified pressure time product per minute
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Physiological Comparison of High-flow Nasal Cannula, Helmet Pressure Support Ventilation and Continuous Positive Airway Pressure During Acute Hypoxemic Respiratory Failure: a Randomized Cross-over Study
Acronym: HIGHFLOWHELMET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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