NCT06594601

Brief Summary

In a population of ARDS patients, we explore the influence of different PEEP levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal PEEP and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3D-EIT.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 2, 2024

Last Update Submit

September 10, 2024

Conditions

Keywords

ARDSEIT3D-EIT

Outcome Measures

Primary Outcomes (1)

  • OD/CL and optimal PEEP monitored by EIT

    Monitoring the lung collapse and overdistension region by EIT at different PEEP levels. Measure the optimal PEEP level based on collapse and overdistension rate.

    5-10min

Secondary Outcomes (4)

  • ventilation distribution monitored by EIT

    5-10min

  • GI monitored by EIT

    5-10min

  • CoV monitored by EIT

    5-10min

  • V/Q monitored by EIT

    5-10min

Study Arms (2)

lung recruitment potential assessed by 3D EIT in ARDS

Diagnosis of ARDS was based on the Berlin definition, who have receivied mechanical ventilation. The enrolled patients received a lung recruitment potential assessment by 3D EIT( as the follwoing mentioned )

Procedure: lung recruitment potential assessed by 3D EIT

PEEP titration by 3D EIT for ARDS

Diagnosis of ARDS was based on the Berlin definition, who have receivied mechanical ventilation. The enrolled patients received a lung PEEP tirtation by 3D EIT( as the follwoing mentioned )

Procedure: PEEP titration by 3D eit

Interventions

Patients were ventilated based on the ARDS-Net suggestions. The patients were kept at supine position. The lung recruitment potential assessed by 3D EIT was as follows: 1. All patients were under pressure control mode (driving pressure 12-15 cmH2O with a tidal volume of 6-8 ml/kg predicted body weight, respiration rate12-15 bpm). 2. PEEP was switched to a zero end-expiratory pressure (ZEEP) for 10 min, and FiO2 was titrated to obtain peripheral oxygen saturation (SpO2 ) \> 90%. 3. PEEP was stepwise increase from 0 to 15 cmH2O PEEP in steps of 5cm H2O every 3min.And 3D EIT was used to assess lung recruitment potential.

lung recruitment potential assessed by 3D EIT in ARDS

Patients were ventilated based on the ARDS-Net suggestions. The patients were kept at supine position. The PEEP titriatino by 3D EIT fwas as follows: 1. All patients were under pressure control mode (driving pressure 12-15 cmH2O with a tidal volume of 6-8 ml/kg predicted body weight, respiration rate12-15 bpm). 2. RM: PEEP was switched to a 21cmH2O for 2min, and FiO2 was titrated to obtain peripheral oxygen saturation (SpO2 ) ≥90%. 3. PEEP was stepwise decrease from 21 to 0 cmH2O PEEP in steps of 3cm H2O every 2min. 4. 3D EIT was used to monitor regional ventilation distribution during PEEP titration.

PEEP titration by 3D EIT for ARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ARDS on mechanical ventilation.

You may qualify if:

  • patients on mechanical ventilation.
  • Diagnosis of ARDS was based on the Berlin definition
  • lung recruitment potential assessment and PEEP titration was proper for the ARDS patients determined by the attending doctor

You may not qualify if:

  • Under 18 years of age.
  • Pregnant women;
  • Ribcage malformation
  • Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
  • Hemodynamic instability, unable to tolerate high PEEP;
  • High-risk individuals with pneumothorax, mediastinal emphysema, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Huaiwu He, PhD

    Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR
  • Yun Long, PhD

    Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 19, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

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