Transpulmonary Pressure in Right Ventricle Protection of ARDS

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05629832

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Acute Cor Pulmonale	Procedure: mechanical ventilation strategy guided by transpulmonary pressure	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTP group	Procedure: mechanical ventilation strategy guided by transpulmonary pressure 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.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: PTP group

Procedure: mechanical ventilation strategy guided by transpulmonary pressure

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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

Pulmonary vascular resistance (PVR) [5 days]
PVR will measured by Swan-Ganz catheter
Pulmonary vascular compliance [5 days]
Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beijing Chao Yang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiao Tang, Doctor, Beijing Chao Yang Hospital

ClinicalTrials.gov Identifier:

NCT05629832

Other Study ID Numbers:

Ptp right ventricle protection

First Posted:

Nov 29, 2022

Last Update Posted:

Dec 1, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Pulmonary Heart Disease

Syndrome

Study Results

No Results Posted as of Dec 1, 2022