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

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

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）.

Study Overview

• Status: Completed
• Conditions: ARDS, Human; PEEP, Occult; Esophageal and Pleural Pressure
• Intervention / Treatment: Other: PEEP adjustment

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients all the moderate to severe ARDS with P/F<200 no contraindication to esophageal catheter

Description

Inclusion Criteria:

- aged over 18 all the moderate to severe ARDS patients invasive mechanical ventilation

Exclusion Criteria:

• aged<18 contraindication to esophageal catheter

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type I: ΔPes≥30%ΔPEEP	Other: PEEP adjustment; adjusting PEEP about 3-5cmH2O (increase or decrease)
Type II: ΔPes<30%ΔPEEP	Other: PEEP adjustment; adjusting PEEP about 3-5cmH2O (increase or decrease)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the changes of esophageal pressure during the PEEP titration	March 1st to May 31st, 2022

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Shuyang Zhang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 29, 2022

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Positive-Pressure Respiration, Intrinsic
• Other Study ID Numbers: ZS-2458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No