Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS

NCT ID: NCT05767125

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APRV Group

Patients with moderate-to-severe ARDS were supported with APRV.

Group Type EXPERIMENTAL

APRV

Intervention Type DEVICE

Patients with moderate-to-severe ARDS were supported with APRV.

LTV Group

Patients with moderate-to-severe ARDS were supported with LTV.

Group Type ACTIVE_COMPARATOR

LTV

Intervention Type DEVICE

Patients with moderate-to-severe ARDS were supported with LTV.

Interventions

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APRV

Patients with moderate-to-severe ARDS were supported with APRV.

Intervention Type DEVICE

LTV

Patients with moderate-to-severe ARDS were supported with LTV.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients aged ≥18 and ≤80 years;
2. Moderate-to-severe ARDS patients according to the Berlin definition;
3. Endotracheal mechanical ventilation ≤48 h before enrollment;
4. Expected to require continuous invasive mechanical ventilation ≥72 h.

Exclusion Criteria

1. Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
2. Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker);
3. Pulmonary interstitial lesions;
4. End-stage of chronic disease, with an expected survival period of \<6 months;
5. Body mass index \>35 kg/m2;
6. Refractory shock;
7. Intracranial hypertension;
8. Pregnant and parturient woman;
9. Intra-abdominal pressure persisted \> 20 mmHg and could not be relieved within 24 hours;
10. Severe thoracic deformity;
11. Severe cardiac dysfunction;
12. Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output;
13. Pulmonary embolism;
14. Extracorporeal membrane oxygenation is needed;
15. Prone positioning was performed before randomization;
16. Patients who have participated in other clinical trials within 30 days;
17. Patients who have not signed informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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XiaoJing Zou,MD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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You Shang, prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaojing Zou, prof.

Role: CONTACT

+862785351606

You Shang, prof.

Role: CONTACT

+862785351607

Facility Contacts

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Yongran WU, master

Role: primary

18627004016 ext. 027-85351607

References

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Zou X, Zhang H, Wu Y, Li R, Gao X, Wang A, Zhao X, Yang X, Shu H, Qi H, Fu Z, Yuan S, Ma Y, Yang L, Shang Y, Zhao Z. Physiologic Comparison of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation in ARDS: A Randomized Controlled Trial. Chest. 2025 Feb;167(2):453-465. doi: 10.1016/j.chest.2024.08.050. Epub 2024 Sep 17.

Reference Type DERIVED
PMID: 39299389 (View on PubMed)

Other Identifiers

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WUHICU202302

Identifier Type: -

Identifier Source: org_study_id

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