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

NCT04241861 | Completed

• 1 other identifier: 2693
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Failure; Hypoxemia

Outcome Measures

Primary Outcomes (2)

• Inspiratory effort

  The negative deflection in esophageal pressure during inspiration

  40 minutes

• Tidal volume

  The tidal change in lung impedance, assessed by electrical impedance tomography

  40 minutes

Secondary Outcomes (14)

• Oxygenation

  40 minutes

• Tidal volume distribution

  40 minutes

• Carbon dioxide

  40 minutes

• Respiratory rate

  40 minutes

• Dyspnea

  40 minutes

Study Arms (3)

High-flow oxygen therapy

EXPERIMENTAL

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%.

Other: Respiratory support (High-flow oxygen therapy)

Helmet PSV

EXPERIMENTAL

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.

Other: Respiratory support (Helmet PSV)

Helmet CPAP

EXPERIMENTAL

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.

Other: Respiratory support (Helmet CPAP)

Interventions

Respiratory support (High-flow oxygen therapy) OTHER

Noninvasive respiratory support respiratory support

High-flow oxygen therapy

Respiratory support (Helmet PSV) OTHER

Noninvasive respiratory support respiratory support

Helmet PSV

Respiratory support (Helmet CPAP) OTHER

Noninvasive respiratory support respiratory support

Helmet CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Respiratory rate\>25 bpm.
• 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.
• PaCO2 \<45mmHg
• Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: collaborator

Study Sites (1)

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

Location

Related Publications (1)

• 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.

  PMID: 36378814 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Antonelli, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

• Domenico L Grieco, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: January 22, 2020
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: February 8, 2021

Record last verified: 2020-01

Locations

IT (1)