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NCT05442073 Clinical Trial

Effect of Initial Empirical PEEP Setting on the Esophageal Pressure-guided PEEP Titration in ARDS

ARDS, Human Clinical Trial

Official title:
Effect of Initial Empirical Positive End-Expiratory Pressure (PEEP) Setting on the Esophageal Pressure-guided PEEP Titration in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05442073
Other study ID # ZS-2458
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date June 29, 2022

Study information
Verified date June 2022
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients, the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal phenotypes could be divided into type I and type II. with Type I （ΔPes≥30%ΔPEEP）and Type II（ΔPes<30%ΔPEEP）.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date June 29, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - aged over 18 all the moderate to severe ARDS patients invasive mechanical ventilation Exclusion Criteria: - aged<18 contraindication to esophageal catheter

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• PEEP adjustment
adjusting PEEP about 3-5cmH2O (increase or decrease)

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the changes of esophageal pressure during the PEEP titration March 1st to May 31st, 2022
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