NCT05629832

Brief Summary

To compare the effect between mechanical ventilation strategy guided by transpulmonary pressure and tranditional lung protective ventilation strategy in acute respiratory distress syndrome for right ventricle protection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 14, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 18, 2026

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

November 14, 2022

Last Update Submit

March 16, 2026

Conditions

Acute Respiratory Distress SyndromeAcute Cor Pulmonale

Outcome Measures

Primary Outcomes (2)

  • Pulmonary vascular resistance (PVR)

    PVR will measured by Swan-Ganz catheter

    3 days

  • Pulmonary vascular compliance

    Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.

    3 days

Study Arms (2)

PTP group

EXPERIMENTAL
Procedure: mechanical ventilation strategy guided by transpulmonary pressure

Control group

NO INTERVENTION

Interventions

mechanical ventilation strategy guided by transpulmonary pressurePROCEDURE

Mechanical ventilation parameters adjust guided by transpulmonary pressure monitoring. For pressure assist control or volumn assit control mode; inspiratory pressure or volumn setting needs to maintain Ppeak less than 25 cm H2O; PEEP was set at such a level that expiratory Ptp stayed between 0 and 5 cm H2O.

PTP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • duration of invasive mechanical ventilation less than 72 hours;
  • meet the diagnostic criteria of Berlin definition for ARDS;
  • age older than 18

You may not qualify if:

  • esophageal surgery or damage;
  • cardiac surgery;
  • severe bronchopleural fistula;
  • serious arrhythmia; pneumothorax;
  • tricuspid stenosis;
  • heparin allergy;
  • chronic pulmonary heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 29, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 18, 2026

Record last verified: 2024-12

Locations

CN(1)