NCT03241654

Brief Summary

In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.Decrease of flow trigger sensitivity might improve homogeneous of tidal volume distribution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 12, 2018

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

August 3, 2017

Last Update Submit

February 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The homogeneity of distribution of tidal volume

    EIT was used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.

    within 20 minutes after changing flow trigger

Secondary Outcomes (1)

  • Changes in global and regional EELV

    within 20 minutes after changing flow trigger

Study Arms (2)

the lowest trigger sensitivity

The flow trigger of ventilator was set as the lowest level of sensitivity.

Procedure: flow trigger

the highest trigger sensitivity

The flow trigger of ventilator was set as the highest level of sensitivity.

Procedure: flow trigger

Interventions

flow triggerPROCEDURE

The flow trigger will be adjust during the pressure assist ventilation.

the highest trigger sensitivitythe lowest trigger sensitivity

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The postoperative patients receiving pressure support ventilation and existing heterogenous ventilation.

You may qualify if:

  • The post operative patients who received pressure support ventilation;
  • After the clinical PEEP was evaluated 5cmH2O, the tidal volume distribution still existed heterogeneity.

You may not qualify if:

  • Under 18 years;
  • History of diaphragm dysfunction and surgery;
  • Central respiratory drive dysfunction;
  • history of esophageal, gastric or lung surgery;
  • The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian-Xin Zhou

Beijing, Beijing Municipality, 100050, China

Location

Study Officials

  • Jian-Xin Zhou, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 7, 2017

Study Start

May 1, 2017

Primary Completion

August 20, 2017

Study Completion

February 1, 2018

Last Updated

February 12, 2018

Record last verified: 2017-08

Locations