Clinical trial NCT04241861: High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Hypoxemia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
First posted: 2020-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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:

1. Respiratory rate\>25 bpm.
2. PaO2/FiO2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°C, FiO2 set to achieve a SpO2 \>92% and \<98%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
3. PaCO2 \<45mmHg
4. Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.
5. Written informed consent

Exclusion Criteria:

* Exacerbation of asthma or chronic obstructive pulmonary disease;
* Cardiogenic pulmonary oedema;
* Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed Shock
* Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
* Glasgow coma scale \<13;
* Recent head surgery or anatomy that prevent the application of helmet or nasal cannula to patient's face.

Primary outcomes:
measure: Inspiratory effort
timeFrame: 40 minutes
measure: Tidal volume
timeFrame: 40 minutes
Secondary outcomes:
measure: Oxygenation
timeFrame: 40 minutes
measure: Tidal volume distribution
timeFrame: 40 minutes
measure: Carbon dioxide
timeFrame: 40 minutes
measure: Respiratory rate
timeFrame: 40 minutes
measure: Dyspnea
timeFrame: 40 minutes
measure: Comfort
timeFrame: 40 minutes
measure: Global impedance-derived End-expiratory lung volume
timeFrame: 40 minutes
measure: Regional impedance-derived End-expiratory lung volume
timeFrame: 40 minutes
measure: Dynamic transpulmonary driving pressure
timeFrame: 40 minutes
measure: Global impedance-derived lung dynamic strain
timeFrame: 40 minutes
measure: Regional impedance-derived lung dynamic strain
timeFrame: 40 minutes
measure: Respiratory system dynamic compliance
timeFrame: 40 minutes
measure: Pendelluft
timeFrame: 40 minutes
measure: Work of breathing
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitaro A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Massimo Antonelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Domenico L Grieco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC.