Tokyo, June 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061831) titled 'Evaluation of optimal ventilator settings during esophageal endoscopic submucosal dissection under general anesthesia' on June 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - St. Luke's International Hospital
Condition:
Condition - Early esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To compare the operability and safety of esophageal endoscopic submucosal dissection (ESD) with and without positive end-expiratory pressure (PEEP).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - No PEEP group (PEEP 0 cmH2O)
Interventions/Control_2 - PEEP group (PEEP 5-10 cmH2O)
Eligibility:
Age-lower limit - 18
years-old
= 35 kg/m2)
4.Patients with severe heart failure or unstable hemodynamic status
5.Patients with active respiratory infection
6.Patients considered unsuitable for study participation by the principal investigator or sub-investigators
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 08 Day
Anticipated trial start date - 2026 Year 06 Month 23 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070753
Disclaimer: Curated by HT Syndication.
