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Clinical Trials/NCT05389735
NCT05389735
Unknown
Not Applicable

Evaluation of Ventilation Distribution With Electrical Impedance Tomography in Mechanically Ventilated Patients After Surgery: a Prospective Observational Study

Osaka University1 site in 1 country130 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Electrical Impedance Tomography
Sponsor
Osaka University
Enrollment
130
Locations
1
Primary Endpoint
Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

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