Recruitment Maneuver After Bronchoalveolar Lavage in ARDS... | NCT05372731

Studies
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients

NCT05372731

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Oct 28, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Acute Respiratory Distress Syndrome

Interventions

Recruitment Maneuver

Countries

Not provided

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2022Estimated

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Apr 20, 2022

First Submission Date that Met QC Criteria

May 12, 2022

First Posted Date

May 13, 2022Actual

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

Oct 27, 2022

Last Update Posted Date

Oct 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ling Liu, Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Southeast University, ChinaPrincipal Investigator

Lead Sponsor

Southeast University, ChinaOTHER

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

ARDS caused by pneumonia is one of the main reasons for ICU admission in critically ill patients, and also a common complication in patients admitted to ICU with invasive mechanical ventilation. Bronchoalveolar lavage (BAL) is the main diagnostic method for these patients, which often leads to alveolar collapse and exacerbates hypoxemia. In clinical practice, recruitment maneuver (RM) is often used immediately after BAL to prevent such a situation, but there is a lack of data on RM after BAL.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RM after BAL	Experimental	patients underwent RM after BAL	Other: Recruitment Maneuver
Non-RM after BAL	No Intervention	patients did not undergo RM after BAL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recruitment Maneuver	Other	RM after BAL	RM after BAL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the ratio of tidal volume in the BAL side and the other side	distribution of tidal volume monitored by electrical impedance tomography from the BAL side to the other side	up to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio	partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio	up to 24 hours
respiratory system compliance (the tidal volume to the driving pressure ratio)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with invasive mechanical ventilation;
Patients who diagnosed with ARDS according to the Berlin definition
There are indications for bronchoalveolar lavage

Exclusion Criteria:

Patients with contraindications for EIT procedures;
Patients with contraindications for RM;
Previous chronic respiratory diseases (long-term home oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD);
Pregnancy;
Refusal to sign informed consent

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ling liu, phD	Contact	86-25-83272201		liulingdoctor@126.com
ling liu, phD	Contact	86-25-83272201

Overall Officials

Name	Affiliation	Role
ling liu, phD	Zhongda Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided