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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05372731
Other study ID # BAL20220420
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 30, 2022
Est. completion date December 30, 2022

Study information

Verified date October 2022
Source Southeast University, China
Contact ling liu, phD
Phone 86-25-83272201
Email liulingdoctor@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Recruitment Maneuver
RM after BAL

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Southeast University, China

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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) up to 24 hours
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