Clinical Trial: Electrical impedance tomography assessment of changes in regional lung ventilation associated with respiratory effort, body positioning, and noninvasive positive-pressure ventilation in patients with acute respiratory failure transported to the emergency department: a prospective observational study (Japan)

Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063323) titled 'A study using electrical impedance tomography to assess lung ventilation and its changes with body positioning and noninvasive ventilation in patients with acute respiratory failure in the emergency department' on Oct. 16.

Study Type: Observational

Primary Sponsor: Institute - Yamagata University

Condition: Condition - Acute respiratory failure in patients presenting to the emergency department Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to prospectively evaluate changes in regional lung ventilation assessed using electrical impedance tomography (EIT) in patients with acute respiratory failure presenting to the emergency department, in relation to respiratory effort, clinically indicated changes in body position, and the initiation of noninvasive positive-pressure ventilation (NPPV). The primary objective is to determine the change in the proportion of ventilation reaching dependent lung regions from immediately before to 15 minutes after NPPV initiation. Secondary objectives are to evaluate temporal changes in EIT parameters through 60 minutes after NPPV initiation and to explore their associations with respiratory effort, body positioning, and clinical outcomes, including NPPV failure within 48 hours. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older who are transported to or present at the emergency department of Yamagata University Hospital. Patients with acute respiratory failure who require oxygen therapy, HFNC, or NPPV and are considered by the attending physician suitable for EIT measurement during spontaneous breathing. Written informed consent is obtained from the patient or a legally acceptable representative. At least one analyzable EIT waveform at T0 and respiratory physiological parameters recorded at the same time are available. Key exclusion criteria - Patients requiring immediate tracheal intubation or another invasive procedure because of cardiopulmonary arrest, impending respiratory arrest, shock, or another critical condition in which EIT application could interfere with emergency care. Patients in whom the EIT electrode belt cannot be safely applied because of chest trauma, burns, extensive skin lesions, a chest tube fixation site, or another relevant condition. Patients with a contraindication or exclusion specified in the instructions for use of the EIT device, including implanted electronic devices when applicable. Patients from whom an analyzable EIT signal cannot be obtained because of severe agitation, excessive body movement, or body habitus. Patients who lack decision-making capacity and for whom written informed consent cannot be obtained from a legally acceptable representative within the enrollment period. Patients with a do-not-intubate (DNI) decision in place at the time of enrollment. Patients considered unsuitable for participation by the principal investigator or attending physician. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 19 Day Date of IRB - 2026 Year 09 Month 15 Day Anticipated trial start date - 2026 Year 10 Month 20 Day Last follow-up date - 2029 Year 06 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072481

Disclaimer: Curated by HT Syndication.