The Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients

The Relevance and Consistency Study of Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients

The pathophysiological characteristics of respiratory failure on exacerbation of chronic pulmonary obstructive disease are the rapid deteriorate of respiratory symptoms, combined with aggravated flow limitation, gas trapping, dynamic pulmonary hyperinflation (DPH), therefore the intrinsic PEEP (PEEPi) increases. It is worthwhile to explore bedside methods to quantify the changes in dynamic pulmonary hyperinflation to guide safe and effective mechanical ventilation in airflow limited patients.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Diagnostic test: the changes of end expiratory lung impedence; Diagnostic test: the changes of end expiratory lung volume

Detailed Description

The study hypothesizes that the electrical impedence tomography (EIT) measured the changes of end expiratory lung impedence (△EELI） could accurately predict the changes of end expiratory lung volume （△EELV） measured by passive expiratory in controlled mechanical ventilated exacerbation COPD patients. The research intended to conduct a research to explore the relationship between △EELI and △EELV induced by external PEEP changes in ventilated exacerbation COPD patients.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Fu, MD; Phone Number: +8602083062882; Email: hooray_009@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical
      • Contact: Wei Fu, MD; Phone Number: +8602083062882; Email: hooray_009@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2022.7-2023.1 exacerbation COPD invasive ventilated patients admitted to the first affiliated Guangzhou medical university; 35 to 80 years old; in stable condition judged by clinicians

Exclusion Criteria:

• SpO2<88%; instable hemodynamic (MAP<65mmHg；Norepinephrine> 0.1ug/kg.min); pregnancy; 4 hour intravenous diuretics use before research; chest deformity and trauma, subpleural pulmonary bulla; implanted electronic devices(cardiac pacemaker, implantable cardioversion defibrillator,ect); tumour or other organ dysfunction; refuse to signature the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEP titration for mechanical ventilated AECOPD patients; Pre- and post-self-controlled trials for invasive mechanical ventilated AECOPD patients during PEEP titration.	Diagnostic test: the changes of end expiratory lung impedence; the changes of end expiratory lung impedence measured by EIT; Other Names: △EELI; Diagnostic test: the changes of end expiratory lung volume; the changes of end expiratory lung volume measured by apnea method; Other Names: △EELV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of end expiratory lung volume	measured by EIT and IC maneuver	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intrinsic PEEP	measured by Esophageal balloon catheters	10 minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Anticipated): October 8, 2023
• Study Completion (Anticipated): October 8, 2023

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: mechanical ventilation; COPD; dynamic pulmonary hyperinflation; end expiratory lung impedence
• Other Study ID Numbers: FAHGuangzhou_20220711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No