Clincosm LogoSign in Get a demo

Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients

Sponsor
Southeast University, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05372731
Collaborator
(none)
40
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Recruitment Maneuver
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RM after BAL

patients underwent RM after BAL

Other: Recruitment Maneuver
RM after BAL
No Intervention: Non-RM after BAL

patients did not undergo RM after BAL

Outcome Measures

Primary Outcome Measures

  1. the ratio of tidal volume in the BAL side and the other side [up to 24 hours]

    distribution of tidal volume monitored by electrical impedance tomography from the BAL side to the other side

Secondary Outcome Measures

  1. partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio [up to 24 hours]

    partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio

  2. respiratory system compliance (the tidal volume to the driving pressure ratio) [up to 24 hours]

    respiratory system compliance was calculated by dividing expiratory tidal volume by the driving pressure (plateau pressure minus positive end-expiratory pressure)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Adult patients with invasive mechanical ventilation;

  2. Patients who diagnosed with ARDS according to the Berlin definition

  3. There are indications for bronchoalveolar lavage

Exclusion Criteria:

  1. Patients with contraindications for EIT procedures;

  2. Patients with contraindications for RM;

  3. Previous chronic respiratory diseases (long-term home oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD);

  4. Pregnancy;

  5. Refusal to sign informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Southeast University, China

Investigators

  • Principal Investigator: ling liu, phD, Zhongda Hospital Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ling Liu, Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Southeast University, China
ClinicalTrials.gov Identifier:
NCT05372731
Other Study ID Numbers:
  • BAL20220420
First Posted:
May 13, 2022
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury

Study Results

No Results Posted as of May 13, 2022