Physiological Effects of APRVplus and TCAV in ARDS | NCT06748807

Studies
Physiological Effects of APRVplus and TCAV in ARDS

NCT06748807

Sponsor

West China Hospital

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Interventions

APRVplus
TCAV

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2023Actual

Primary Completion Date

Dec 15, 2024Actual

Completion Date

Dec 15, 2024Actual

First Submitted Date

Dec 19, 2024

First Submission Date that Met QC Criteria

Dec 19, 2024

First Posted Date

Dec 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. This study aims to compare the physiological effects of two types of APRV ventilation strategy, Early Pathophysiology-driven APRV (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV), through randomized crossover trials, providing evidence for clinical application and further research on APRV.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
APRVplus	Experimental	An Early Pathophysiology-driven Airway Pressure Release Ventilation	Procedure: APRVplus
TCAV	Other	Time Controlled Adaptive Ventilation (TCAV)	Procedure: TCAV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
APRVplus	Procedure	Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus)	APRVplus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
△PL（PLThigh - PLTlow)	Transpulmonary pressure swings (△PL) equal to PLThigh - PLTlow	during the mechanical ventilation procedure

Secondary Outcomes

Measure	Description	Time Frame
EtCO2	end-tidal carbon dioxide	during the mechanical ventilation procedure
GI	global inhomogeneity	during the mechanical ventilation procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intubated and mechanically ventilated patients
meet the 2023 global new definition of ARDS

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital, Sichuan University		Chengdu	Sichuan	610041	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided