Evaluation of Postoperative Ventilation Distribution With Electrical Impedance Tomography

• Conditions: Electrical Impedance Tomography

• Registration Number: NCT05389735
• Lead Sponsor: Osaka University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-15
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

1. 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
2. Patients with DNR (do-not-resuscitate)
3. Patients undergoing home ventilator management before surgery
4. Preoperative, hypocardiac function patients (echocardiography shows left ventricular ejection fraction of 40% or less, or NYHA III degree or more +)
5. Patients with a ventricular assist device
6. Patients with extracorporeal membrane oxygenation (VV or VA)
7. History of neuromuscular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score	up to 12 weeks	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Osaka University; 🇯🇵 Osaka, Japan