NCT06790875

Brief Summary

The goal of this clinical trial is to learn how low tidal volume ventilation (LTV) and airway pressure release ventilation (APRV) affect lung tissue mechanics in adults with ARDS. The main questions it aims to answer are: Does LTV or APRV improve lung tissue mechanics in patients with ARDS under mechanical ventilation? Researchers will compare LTV and APRV to see which ventilation mode works better for improving lung mechanics and patient safety.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 10, 2025

Last Update Submit

January 19, 2025

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDSMPDRRS

Outcome Measures

Primary Outcomes (1)

  • Impact of low tidal volume vs airway pressure release ventilation on Dynamic relative regional lung strain（DRRS）

    Maximum 4 hours

Secondary Outcomes (3)

  • mechanical power（MP）

    Maximum 4 hours

  • platform pressure

    Maximum 4 hours

  • mean airway pressure

    Maximum 4 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

Airway Pressure Release Ventilation (APRV)

Device: Airway Pressure Release Ventilation (APRV)

Control group

NO INTERVENTION

Low tidal volume ventilation

Interventions

Airway Pressure Release Ventilation (APRV)DEVICE

In this arm, participants will receive airway pressure release ventilation (APRV), a form of pressure-controlled mechanical ventilation. The high pressure (Phigh) is set based on the plateau pressure of the LTV mode, with a low pressure (Plow) set at 0 cmH₂O. The high pressure time (Thigh) will be set to 4-6 seconds to maintain alveolar recruitment, while the low pressure time (Tlow) will be set to 0.2-0.6 seconds to optimize expiratory flow. This arm aims to evaluate the effects of APRV on lung tissue mechanics, oxygenation, and overall respiratory function in ARDS patients.

Intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets the diagnostic criteria of the 2023 Global New Definition of ARDS.
  • Age: 18-80 years.
  • PaO2/FiO2 ≤ 200.
  • Within 12 hours of invasive mechanical ventilation treatment.
  • Obtain consent from the patient or their family members to participate in the study, and sign the informed consent form.

You may not qualify if:

  • Age \< 18 years or \> 80 years.
  • Uncorrected shock of any type.
  • Chronic obstructive pulmonary disease (COPD), pulmonary embolism, right heart failure, pulmonary hypertension, or severe arrhythmia.
  • Contraindications for using Electrical Impedance Tomography (EIT) (extensive chest skin damage, infection, pacemaker implantation, implanted automatic defibrillator, etc.), pneumothorax, mediastinal emphysema, or large pleural effusion.
  • Pregnant or breastfeeding women.
  • Patients planned for ECMO treatment.
  • Patients currently participating in or previously enrolled in other clinical studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Related Publications (1)

  • Protti A, Cressoni M, Santini A, Langer T, Mietto C, Febres D, Chierichetti M, Coppola S, Conte G, Gatti S, Leopardi O, Masson S, Lombardi L, Lazzerini M, Rampoldi E, Cadringher P, Gattinoni L. Lung stress and strain during mechanical ventilation: any safe threshold? Am J Respir Crit Care Med. 2011 May 15;183(10):1354-62. doi: 10.1164/rccm.201010-1757OC. Epub 2011 Feb 4.

    PMID: 21297069RESULT

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

Xiaojing Zou Professor

CONTACT

1399551863013995518630@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 24, 2025

Study Start

November 20, 2024

Primary Completion

November 20, 2025

Study Completion

November 20, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)