Proportional Assist Ventilation vs Pressure Support Venti... | NCT00790725

Studies
Proportional Assist Ventilation vs Pressure Support Ventilation

NCT00790725

Sponsor

Massachusetts General Hospital

Status

Terminated

Last Update Posted

Apr 25, 2012Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Respiration, Artificial

Interventions

Proportional Assist Ventilation
Pressure Support Ventilation

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The patient population in RACU has changed significantly, we can not find potential subjects to recruit. The enrollment rate has reached zero.

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Nov 11, 2008

First Submission Date that Met QC Criteria

Nov 11, 2008

First Posted Date

Nov 13, 2008Estimated

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

Apr 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Name	Class
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. These artificial ventilation types are:

Pressure support ventilation; the standard ventilation that we use for the patients in the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant air pressure to assist patients with their breathing.
Proportional assist ventilation; a newer way of helping people with their breathing. The air pressure provided by proportional assist ventilation ventilators varies with the size of the breath that a person takes.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PAV	Other	Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU	Other: Proportional Assist Ventilation
PS	Other	Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU	Other: Pressure Support Ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proportional Assist Ventilation	Other	Proportional Assist Ventilation will be used to ventilate the patients.	PAV

Measure	Description	Time Frame
Length of time mechanically ventilated in the RACU		30 days

Measure	Description	Time Frame
Sleep quality		48 hours
Inflammatory mediator levels		30 days
Hospital mortality

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the RACU.
Age 18 years or older.

Exclusion Criteria:

Patients who are weaned from ventilatory support within the first 72 hours of transfer to the RACU. Even though these patients had been randomized, they will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
High spinal cord injury
Immunosuppressed patients receiving chemotherapy or radiation therapy (< 2 months after chemotherapy or radiation therapy).
Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
High risk of mortality within 3 months (severe neurological damage and cancer patients in terminal stages of the disease).
Patients unable to trigger the ventilator for any reason.
Any patient who is not considered a candidate for weaning from ventilatory support
Patients consented for another interventional study.
Patients requiring more than 30 days to wean once randomized will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.

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

Name	Affiliation	Role
Robert M Kacmarek, PhD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy