Ventilator Mode and Respiratory Physiology | NCT06624254

Studies
Ventilator Mode and Respiratory Physiology

NCT06624254

Sponsor

University of California, San Diego

Status

Enrolling by invitation

Last Update Posted

Oct 2, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Pulmonary Disease
Respiratory Failure
Respiratory Effort
Breathing Mechanics

Interventions

lung mechanics, respiratory drive and effort

Countries

United States

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2024Actual

Primary Completion Date

Sep 2029Estimated

Completion Date

Sep 2029Estimated

First Submitted Date

Sep 30, 2024

First Submission Date that Met QC Criteria

Sep 30, 2024

First Posted Date

Oct 2, 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

Sep 30, 2024

Last Update Posted Date

Oct 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alex Pearce, Principal Investigator, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

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

Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. APC can inadvertently deliver high tidal volumes, which maybe harmful. High tidal volumes may be unrecognized by the provider, due to the complexities of ventilator algorithms and patient interactions. The objective of this aim is to identify risk factors for excess tidal volumes in patients on adaptive pressure control.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adaptive Pressure Control		On adaptive pressure control mode with acute respiratory failure	Other: lung mechanics, respiratory drive and effort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lung mechanics, respiratory drive and effort	Other	Patient lung mechanics and respiratory drive and effort will be measured	Adaptive Pressure Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Excess tidal volume	Exhaled tidal volume greater than 2cc/kg ideal body weight above intended or set tidal volume	From enrollment to end of monitoring at 4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to ICU with acute respiratory failure
On adaptive pressure control mode of ventilation
Tidal volumes set between 5-8 cc/kg ideal body weight

Exclusion Criteria:

Current use of neuromuscular blockade
Inability to obtain consent from patient or surrogate decision maker
Treating clinician refusal

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

Human subjects admitted to the intensive care unit requiring invasive mechanical ventilation for acute respiratory failure on adaptive pressure control modes of ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alex Pearce, MD	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego Health		La Jolla	California	92037	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

reasonable requests for IPD will be considered by the investigators

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided