Clinical Trial: Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial) (Japan)

Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060233) titled 'Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)' on Dec. 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Esophageal or gastroesophageal junction cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The primary objective is to demonstrate that individualized PEEP provides a stronger protective effect on the lungs than uniformly applied PEEP. The secondary objective is to clarify the mechanisms by which different PEEP settings affect outcomes, particularly the involvement of interorgan crosstalk between the lungs and kidneys. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - To determine the optimal PEEP level, the individualized group increases the PEEP level by 2 cmH2O per minute from 0 to 16 cmH2O during one-lung ventilation without changing the tidal volume or ventilation rate. The PEEP level at which the drive pressure is minimized is defined as the optimal PEEP level for that patient. The optimal PEEP level is used during one-lung ventilation in the individualized group. Interventions/Control_2 - The fixed group has the PEEP level fixed at 5 cmH2O during one-lung ventilaiton.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Subjects aged 20 to 80 years at the time of consent. 2. Subjects undergoing minimally invasive esophagectomy in the prone position using thoracoscopic or robotic assistance. 3. Subjects who agree to undergo combined epidural anesthesia. 4. Subjects who have received a thorough explanation of this study and fully understood the requirements, and who have provided their own voluntary written consent. Key exclusion criteria - 1. Patients undergoing gastrointestinal reconstruction using intrathoracic anastomosis 2. Patients with severe obesity (body mass index 35 kg/m2 or greater) 3. Patients with severe chronic obstructive pulmonary disease (FEV1% < 50%) 4. Patients with interstitial pneumonia (including patients suspected of having interstitial pneumonia based on diagnostic imaging) 5. Patients with giant lung cysts (emphysematous lung cysts occupying one-third or more of one thoracic cavity) 6. Patients with a tracheostomy 7. Patients with pulmonary hypertension or intracranial hypertension, even if mild, who are considered to be unable to tolerate hypercapnia 8. Other subjects deemed inappropriate by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 08 Day Date of IRB - 2025 Year 12 Month 05 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068892

Disclaimer: Curated by HT Syndication.