NCT03549910

Brief Summary

Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial. Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
2.5 years until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

May 15, 2018

Last Update Submit

April 10, 2024

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality at Day28

    Day 28

Secondary Outcomes (7)

  • Mechanical ventilation free days

    Day 28

  • oxygenation

    from enrollment to Day7

  • repiratory system compliance

    from enrollment to Day7

  • MAP

    during the mechanical ventilation procedure

  • sedation depth

    during the mechanical ventilation procedure

  • +2 more secondary outcomes

Other Outcomes (1)

  • adverse events related to mechanical ventilation

    during the mechanical ventilation procedure

Study Arms (2)

Early use of APRVplus protocol in ARDS

EXPERIMENTAL

physiology-driven APRVplus protocol

Procedure: APRVplus protocol

Low tidal volume ventilation

OTHER

Low tidal volume lung protective ventilation

Procedure: Low tidal volume ventilation

Interventions

APRVplus protocolPROCEDURE

Physiology-driven APRVplus protocol

Early use of APRVplus protocol in ARDS
Low tidal volume ventilationPROCEDURE

Low tidal volume lung protective ventilation

Low tidal volume ventilation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
  • receiving tracheal intubation and mechanical ventilation was no longer than 48 hours

You may not qualify if:

  • Pregnancy
  • The expected duration of mechanical ventilation was less than 48 hours
  • Intracranial hypertension (suspected or confirmed)
  • Neuromuscular disorders that are known to prolong the need for mechanical ventilation
  • Known or suspected chronic obstructive pulmonary disease(COPD)
  • Terminal stage of disease
  • Pneumothorax (drained or not)at enrollment
  • Treatment with extracorporeal support (ECMO) at enrollment
  • There was a lack of commitment to life support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • Zhou Y, Cheng J, Zhu S, Dong M, Lv Y, Jing X, Kang Y. Early pathophysiology-driven airway pressure release ventilation versus low tidal volume ventilation strategy for patients with moderate-severe ARDS: study protocol for a randomized, multicenter, controlled trial. BMC Pulm Med. 2024 May 23;24(1):252. doi: 10.1186/s12890-024-03065-y.

    PMID: 38783268DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Kang Yan

    Department of Critical Care Medicine

    STUDY CHAIR

Central Study Contacts

Yongfang Zhou

CONTACT

86 18140212276zyfmg@163.com

Yan Kang

CONTACT

86 18980601566kang_yan_123@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of Critical Care Medicine

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 8, 2018

Study Start

December 10, 2020

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

CN(1)