NCT05585060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2023

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

October 15, 2022

Last Update Submit

November 19, 2022

Conditions

Keywords

COPDdynamic pulmonary hyperinflationmechanical ventilationend expiratory lung impedence

Outcome Measures

Primary Outcomes (1)

  • the changes of end expiratory lung volume

    measured by EIT and IC maneuver

    10 minutes

Secondary Outcomes (1)

  • intrinsic PEEP

    10 minutes

Study Arms (1)

PEEP titration for mechanical ventilated AECOPD patients

EXPERIMENTAL

Pre- and post-self-controlled trials for invasive mechanical ventilated AECOPD patients during PEEP titration.

Diagnostic Test: the changes of end expiratory lung impedenceDiagnostic Test: the changes of end expiratory lung volume

Interventions

the changes of end expiratory lung impedence measured by EIT

Also known as: △EELI
PEEP titration for mechanical ventilated AECOPD patients

the changes of end expiratory lung volume measured by apnea method

Also known as: △EELV
PEEP titration for mechanical ventilated AECOPD patients

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rongchang Chen, PhD

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2022

First Posted

October 18, 2022

Study Start

September 13, 2022

Primary Completion

October 8, 2023

Study Completion

October 8, 2023

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations