NCT07504731

Brief Summary

This multicenter, physiological, observational study hypothesizes that in moderate to severe ARDS, trunk inclination unloads the chest wall, but its impact on lung mechanics depends on PEEP levels and lung recruitability.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

3 active sites

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 Progress22%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

March 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 1, 2026

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

March 20, 2026

Last Update Submit

March 25, 2026

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

trunk inclinationlung mechanicspositive end-expiratory pressurelung recruitability

Outcome Measures

Primary Outcomes (1)

  • Transpulmonary driving pressure (ΔPL)

    Physiological parameter calculated as end-inspiratory transpulmonary pressure minus end-expiratory transpulmonary pressure. Transpulmonary pressure is monitored continuously in real time using an esophageal balloon catheter.

    2 hour

Secondary Outcomes (6)

  • Percentage of overdistension and collapse

    2 hours

  • Lung compliance (Clung)

    2 hours

  • Respiratory system compliance (Crs)

    2 hours

  • Chest wall compliance (Ccw)

    2 hours

  • Recruitment-to-inflation (R/I) ratio

    2 hours

  • +1 more secondary outcomes

Study Arms (1)

Intubated mechanically ventilated ARDS patients

Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition

Other: Specific lung recruitment maneuvers and decremental PEEP steps

Interventions

Specific lung recruitment maneuvers and decremental PEEP stepsOTHER

Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment. Followed by a decremental PEEP steps to determine lung mechanics at different PEEP levels. These process will be repeated when patients change to another position. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure will be recorded continuously.

Intubated mechanically ventilated ARDS patients

Eligibility Criteria

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

Intubated mechanically ventilated ARDS patients will be considered for enrollment

You may qualify if:

  • Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \<= 200 mmHg)
  • Under continuous sedation with or without paralysis

You may not qualify if:

  • Age \<18 years
  • Bronchopleural fistula
  • Pure COPD exacerbation
  • Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  • Hemodynamic instability (Systolic BP \< 75 mmHg or MAP \< 60 mmHg despite vasopressors and/or heart rate \< 55 bpm)
  • Contraindications to mobilization (e.g., intracranial hypertension, spinal cord injury)
  • Intra-abdominal hypotension (IAP≥12mmHg)
  • Pregnancy
  • Attending physician deems the transient application of high airway pressures to be unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Fengmei Guo, M.D

CONTACT

+8618255127433fmguo2022@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 1, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 1, 2026

Record last verified: 2025-04

Locations

CN(3)