Personalized Noninvasive Support

Not Applicable

Recruiting

• Conditions: Acute Hypoxic Respiratory Failure

• Registration Number: NCT06202144
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-11
• Study Start: 2024-01-12
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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
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
End-expiratory lung impedance	1 hour	End-expiratory lung impedance, assessed with electrical impedance tomography
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