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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05585060

Collaborator

(none)

Enrollment

Location

Arm

12.8

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Diagnostic Test: the changes of end expiratory lung impedence Diagnostic Test: the changes of end expiratory lung volume	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 13, 2022

Anticipated Primary Completion Date :

Oct 8, 2023

Anticipated Study Completion Date :

Oct 8, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the changes of end expiratory lung volume [10 minutes]
measured by EIT and IC maneuver

Secondary Outcome Measures

intrinsic PEEP [10 minutes]
measured by Esophageal balloon catheters

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangzhou Medical	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

The First Affiliated Hospital of Guangzhou Medical University

Investigators

Study Chair: Rongchang Chen, PhD, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

FuWei, Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University

ClinicalTrials.gov Identifier:

NCT05585060

Other Study ID Numbers:

FAHGuangzhou_20220711

First Posted:

Oct 18, 2022

Last Update Posted:

Nov 22, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by FuWei, Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University

COPD

dynamic pulmonary hyperinflation

mechanical ventilation

end expiratory lung impedence

Study Results

No Results Posted as of Nov 22, 2022