NCT05372731

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

April 20, 2022

Last Update Submit

October 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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)

    up to 24 hours

Study Arms (2)

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

RM after BAL

RM after BAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • ling liu, phD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ling liu, phD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 13, 2022

Study Start

November 30, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share