Back to resultsRecruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Recruitment Maneuver
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Distress Syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RM after BAL
Non-RM after BAL
Arm Description
patients underwent RM after BAL
patients did not undergo RM after BAL
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
respiratory system compliance (the tidal volume to the driving pressure ratio)
respiratory system compliance was calculated by dividing expiratory tidal volume by the driving pressure (plateau pressure minus positive end-expiratory pressure)
Full Information
NCT ID
NCT05372731
First Posted
April 20, 2022
Last Updated
October 27, 2022
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT05372731
Brief Title
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
Official Title
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RM after BAL
Arm Type
Experimental
Arm Description
patients underwent RM after BAL
Arm Title
Non-RM after BAL
Arm Type
No Intervention
Arm Description
patients did not undergo RM after BAL
Intervention Type
Other
Intervention Name(s)
Recruitment Maneuver
Intervention Description
RM after BAL
Primary Outcome Measure Information:
Title
the ratio of tidal volume in the BAL side and the other side
Description
distribution of tidal volume monitored by electrical impedance tomography from the BAL side to the other side
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio
Description
partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio
Time Frame
up to 24 hours
Title
respiratory system compliance (the tidal volume to the driving pressure ratio)
Description
respiratory system compliance was calculated by dividing expiratory tidal volume by the driving pressure (plateau pressure minus positive end-expiratory pressure)
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ling liu, phD
Phone
86-25-83272201
Email
liulingdoctor@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
ling liu, phD
Phone
86-25-83272201
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ling liu, phD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
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