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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05442073
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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）.

Condition or Disease	Intervention/Treatment	Phase
ARDS, Human; PEEP, Occult; Esophageal and Pleural Pressure	Other: PEEP adjustment

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 18 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Effect of Initial Empirical Positive End-Expiratory Pressure (PEEP) Setting on the Esophageal Pressure-guided PEEP Titration in Acute Respiratory Distress Syndrome
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: Jun 29, 2022

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. the changes of esophageal pressure during the PEEP titration [March 1st to May 31st, 2022]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• aged<18 contraindication to esophageal catheter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05442073
• Other Study ID Numbers: ZS-2458
• First Posted: Jul 1, 2022
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Positive-Pressure Respiration, Intrinsic

Study Results

No Results Posted as of Jul 1, 2022