Personalized Noninvasive Support
- Conditions
- Acute Hypoxic Respiratory Failure
- Interventions
- Device: Noninvasive support
- Registration Number
- NCT06202144
- Brief Summary
The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals.
The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.
- Detailed Description
Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O.
Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Acute hypoxemic respiratory failure and PaO2/FiO2<200 mmHg
- PaCO2<45 mmHg
- Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload
- Pregnancy
- Contraindication to helmet support
- Contraindication to esophageal manometry
- Contraindication to electrical-impedance tomography monitoring
- Recent surgery involving the abdomen or the thorax
- Pneumothorax or documented barotrauma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Noninvasive ventilation Noninvasive support Helmet NIV will be delivered in the pressure-support mode, with PEEP=12 cmH2O and pressure support=12 cmH2O Continuous positive airway pressure Noninvasive support Helmet CPAP will be delivered through a high-flow generator and PEEP valve set at 12 cmH2O Personalized Noninvasive support Noninvasive support Helmet noninvasive support, with positive end-expiratory pressure (PEEP)=12 cmH2O and the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O
- Primary Outcome Measures
Name Time Method Tidal volume 1 hour Tidal volume size, assessed with electrical impedance tomography
Transpulmonary driving pressure 1 hour The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure
- Secondary Outcome Measures
Name Time Method End-expiratory lung impedance 1 hour End-expiratory lung impedance, assessed with electrical impedance tomography
Inspiratory effort 1 hour Inspiratory effort, defined as the negative deflection in esophageal pressure
Work of breathing 1 hour Simplified esophageal pressure pressure-time product
Respiratory rate 1 hour Respiratory rate per minute
Blood oxygenation 1 hour PaO2/FiO2 ratio
Corrected minute ventilation 1 hour Minute ventilation (assessed with electrical impedance tomography) normalized to PaCO2
Tidal volume distribution 1 hour Tidal volume distribution in the four lung regions of interest (ventral, mid-ventral, mid-dorsal and dorsal), assessed with electrical impedance tomography
Pendelluft extent 1 hour Pendelluft, assessed with electrical impedance tomography and expressed in % of tidal volume size
Lung compliance 1 hour Defined as the ration of tidal volume to transpulmonary driving pressure
Dyspnea 1 hour Dyspnea, defined through a visual analog scale ((ranging from 0 to 10, with representing most severe dyspnea)
Trial Locations
- Locations (1)
Fondazione Policlinico Universitaro A. Gemelli IRCCS
🇮🇹Rome, Italy