Prediction of Weaning Outcomes by Using Rate of Change of... | NCT00366197

Studies
Prediction of Weaning Outcomes by Using Rate of Change of Rapid Shallow Breathing Index

NCT00366197

Sponsor

Atlantic Health System

Status

Terminated

Last Update Posted

Jan 16, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Rapid Shallow Breathing

Interventions

Not provided

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Jul 2008Actual

First Submitted Date

Aug 17, 2006

First Submission Date that Met QC Criteria

Aug 18, 2006

First Posted Date

Aug 21, 2006Estimated

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

Jan 15, 2014

Last Update Posted Date

Jan 16, 2014Estimated

Description Module

Brief Summary

This trial examines weaning outcomes using the rapid shallow breathing index rate.

Detailed Description

We hypothesize that the trend of the Rapid Shallow Breathing Index or RSBI rate, is a better predictor of weaning outcome than the RSBI as a single value during the weaning trial. patients are recruited during a weaning trial on t-piece and the RSBI during what the RSBI is measured periodically. The outcome is ventilatory status at 24 hours after the weaning trial.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requires need of mechanical ventilation for > 48 hours with a tube size no smaller than 7.5

Exclusion Criteria:

Healthy volunteers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Male and Female

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stanley Fiel, MD	Atlantic Health System	Principal Investigator
Harris Rana, MD	Atlantic Health System	Principal Investigator
Salvatore Ruggiero, MD	Atlantic Health System	Principal Investigator
Erwin Oei, MD	Atlantic Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Morristown Memorial Hospital		Morristown	New Jersey	07962	United States