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

NCT05442073 | Completed

• 1 other identifier: ZS-2458
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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）.

Conditions

ARDS, Human; PEEP, Occult; Esophageal and Pleural Pressure

Outcome Measures

Primary Outcomes (1)

• the changes of esophageal pressure during the PEEP titration

  March 1st to May 31st, 2022

Study Arms (2)

Type I: ΔPes≥30%ΔPEEP

Other: PEEP adjustment

Type II: ΔPes<30%ΔPEEP

Other: PEEP adjustment

Interventions

PEEP adjustment OTHER

adjusting PEEP about 3-5cmH2O (increase or decrease)

Type I: ΔPes≥30%ΔPEEP; Type II: ΔPes<30%ΔPEEP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• aged\<18 contraindication to esophageal catheter

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Positive-Pressure Respiration, Intrinsic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency

Study Officials

• Shuyang Zhang, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: March 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: June 29, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)