Evaluation of Postoperative Ventilation Distribution With Electrical Impedance Tomography

NCT05389735 | Unknown

• 1 other identifier: hi38655072
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative patients require respiratory management . It is known that the intrapulmonary ventilation distribution becomes uneven due to dorsal atelectasis and ventral hyperinflation during mechanical ventilation management, but the incidence in postoperative patients is unknown. EIT is a device that can monitor the ventilation distribution in the lungs over time without being exposed to the bedside. Therefore, for patients at risk of postoperative respiratory complications, use EIT to 1) evaluate the pulmonary ventilation distribution during postoperative ventilation management, 2) pulmonary ventilation distribution and postoperative respiratory organs. The purpose of this study is to clarify the relationship with the severity of complications. A prospective observational study to investigate the relationship between ventilation distribution and prognosis using EIT in patients undergoing mechanical ventilation after adult surgery.

Conditions

Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score

  Dorsal fraction of ventilation(%):The dorsal fraction of ventilation is calculated as the sum of all pixel values in the dorsal half of the EIT image over the sum of all pixel values from the EIT image Postoperative pulmonary complications score(0-5):Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5, with grade zero representing absence of complications, grades 1 to 4 representing increasing (worsening) levels of complications, and grade 5 representing death before hospital discharge.

  up to 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

postoperative patients

You may not qualify if:

• the EIT belt is worn Patients with unstable spine or pelvis due to fractures, etc. Patients with implantable defibrillation and implantable pacemaker Patients with skin lesions such as blisters between the 4th and 5th intercostal spaces where
• Patients with DNR (do-not-resuscitate)
• Patients undergoing home ventilator management before surgery
• Preoperative, hypocardiac function patients (echocardiography shows left ventricular ejection fraction of 40% or less, or NYHA III degree or more +)
• Patients with a ventricular assist device
• Patients with extracorporeal membrane oxygenation (VV or VA)
• History of neuromuscular disease

Sponsors & Collaborators

• Osaka University: lead
• Nihon Kohden: collaborator

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Osaka, Japan

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 25, 2022
• Study Start: October 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

JP (1)