Effect of Early Mobilization on Regional Lung Ventilation... | NCT04081129

Studies
Effect of Early Mobilization on Regional Lung Ventilation Assessed by EIT

NCT04081129

Sponsor

Yun Long

Status

Unknown status

Last Update Posted

Sep 10, 2019Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Critical Illness
Lung Function Decreased
ICU Acquired Weakness

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Sep 3, 2019

First Submission Date that Met QC Criteria

Sep 4, 2019

First Posted Date

Sep 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2019

Last Update Posted Date

Sep 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yun Long, the director of the intensive care medicine, Peking Union Medical College HospitalSponsor-Investigator

Lead Sponsor

Yun LongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Changes in pulmonary ventilation and perfusion by EIT to out-of-bed activity in critically ill patients

Detailed Description

EIT measurements were performed in ICU patients who under out-of-bed activity
Measurement of EIT was taken place at 4 time points: supine position before early mobilization, 30min, 60min during early mobilization, supine positon after early mobilization. All of them were without invasive ventilation. Measurements were made in triplicate at all time points.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
ICU patients with early mobilization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lung regional ventilation distribution	lung regional ventilation distribution was measured by EIT	Hour 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients was performed out-of-bed activity in the ICU department based on doctor order
Age (> 18 years old) and (< 90 years old)

Exclusion Criteria:

Chest skin is injury and cannot be monitored by EIT
The patients or their families refused to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients was performed out-of-bed activity, who were sequentially admitted to the ICU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yun Long	Contact	13911608699		ly_icu@aliyun.com
Siyi Yuan	Contact	15201518815		yuansiyizqh@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34805212	Derived	Yuan S, Chi Y, Long Y, He H, Zhao Z. Effect of Position Change From the Bed to a Wheelchair on the Regional Ventilation Distribution Assessed by Electrical Impedance Tomography in Patients With Respiratory Failure. Front Med (Lausanne). 2021 Nov 4;8:744958. doi: 10.3389/fmed.2021.744958. eCollection 2021.

ID	Term
D016638	Critical Illness
D012131	Respiratory Insufficiency

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders