High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure

NCT ID: NCT04241861

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2021-01-27

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.

Conditions

Respiratory Failure; Hypoxemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-flow oxygen therapy

Nasal high flow oxygen therapy will be delivered with the Optiflow system. Initial set flow will be ≥ 50 /min and flows will be decreased in case of intolerance and/or according to patients' requirements: flows≥30 L/min will be mandatory in all enrolled patients. Humidification chamber (MR860, Fisher and Paykel healthcare, New Zealand) will be set at 37 °C or 34 °C according to patient's comfort33. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.

Group Type: EXPERIMENTAL

Respiratory support (High-flow oxygen therapy)

Intervention Type: OTHER

Noninvasive respiratory support respiratory support

Helmet PSV

Dedicated helmets for noninvasive ventilation will be used and size will be chosen according to neck circumference or according to manufacturer recommendations.

Each patient will be connected to a compressed-gas based ventilator through a bitube circuit with no humidification.

The ventilator will be set in PSV, with the following suggested settings 34-38:

1. initial pressure support≥8-10 cmH2O and adequate to permit of a peak in the inspiratory flow of 100 l/min;

2. positive end-expiratory pressure=10-12 cmH2O and increased to achieve the oxygenation target according to the choice of the attending physician.

3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.

4. Inspiratory flow trigger = 1 l/min or according to the practice of each institution;

5. fastest pressurization time;

6. expiratory trigger: 10-50% of the maximum inspiratory flow;

7. maximum inspiratory time 1.2 second.

Group Type: EXPERIMENTAL

Respiratory support (Helmet PSV)

Intervention Type: OTHER

Noninvasive respiratory support respiratory support

Helmet CPAP

Dedicated helmets for noninvasive ventilation will be uses and size will be chosen according to neck circumference or according to manufacturer recommendations.

Treatment will be delivered through a high-flow generator. The following settings will be applied:

1. Continuous air flow=50-60 L/min.

2. Expiratory positive end-expiratory pressure valve set to achieve a PEEP==10-12 cmH2O and eventually increased to achieve the oxygenation target according to the choice of the attending physician.

3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Pressure inside the helmet will be monitored with a manometer in order to maintain the set PEEP.

Group Type: EXPERIMENTAL

Respiratory support (Helmet CPAP)

Intervention Type: OTHER

Noninvasive respiratory support respiratory support

Interventions

Respiratory support (High-flow oxygen therapy)

Noninvasive respiratory support respiratory support

Intervention Type: OTHER

Respiratory support (Helmet PSV)

Noninvasive respiratory support respiratory support

Intervention Type: OTHER

Respiratory support (Helmet CPAP)

Noninvasive respiratory support respiratory support

Intervention Type: OTHER

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Antonelli, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Domenico L Grieco, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36378814 (View on PubMed)

Other Identifiers

2693

Identifier Type: -

Identifier Source: org_study_id