The Efficacy of Nurse-driven, Protocol Guided Ventilator... | NCT00786617

Studies
The Efficacy of Nurse-driven, Protocol Guided Ventilator Weaning in a Medical-Surgical Intensive Care Unit (ICU)

NCT00786617

Sponsor

St. Luke's-Roosevelt Hospital Center

Status

Completed

Last Update Posted

Mar 20, 2015Estimated

Enrollment

202Actual

Phase

Not provided

Conditions

Vent Weaning in Medical- Surgical ICUs

Interventions

Not provided

Countries

Not provided

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

Mar 2015

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 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 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

Mar 18, 2015

Last Update Posted Date

Mar 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will have a mean length of stay on ventilator at least one day shorter than patients weaned by physician-initiated, non-protocol methods
Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will have al least similar Ventilator, ICU, and Hospital Length Of Stay (LOS) compared to patients weaned by physician-initiated, non-protocol method
Nurse-driven ventilator weaning protocol is well accepted by other services: physicians, nurses, and respiratory therapists.

Detailed Description

Ventilatory support is one of the most common indications for admission to ICU (1).

The duration of mechanical ventilation is associated with several serious complications, increase mortality, prolong ICU stay, and increase hospital cost (7,8).

Traditionally, the process of ventilator weaning is initiated and carried out my physicians.

Recently, there have been few studies that supported the utility of protocol guided weaning algorithms. Its use have been associated with earlier initiation of weaning, leading to shorter ventilator time, and a trend for shorter ICU length-of-stay and lower hospital costs (1,2,4,9) Several studies have also shown the relative safety of utilizing nursing (3) and RT staff alone or in cooperation with medical staff in the weaning of patients from mechanical ventilation (1,2,6).

We recently developed a nurse-driven ventilator weaning protocol for all ICUs at St. Luke's and Roosevelt hospitals. The protocol was approved by the Critical Care Committee and is implemented as of May 2007. All ICU nurses, respiratory therapists, and ICU physicians have been educated on this protocol We plan to prospectively collect data to look at length of stay on mechanical ventilation in patients weaned by nurse-driven ventilator weaning protocol. We plan to compare such data to retrospectively collected ventilator LOS data in patients weaned by physician-initiated ventilator weaning method.

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

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nurse-driven		Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol
Physician-initated		Mechanically ventilated patients weaned by physician-initiated, non-protocol methods

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Length of Stay on Ventilator		up to 5 months

Secondary Outcomes

Measure	Description	Time Frame
ICU mortality		up to 5 months
Hospital mortality		up to 5 months
Treatment intensity and resource allocation: Cost of ICU care per year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receiving MV for at least 24 hours in the ICU
Meeting established protocol criteria for a vent wean trial

Exclusion Criteria:

Patients in whom MV was actively withdrawn for terminal wean
Brain dead patients on MV
Age <18 years old
Transfers from other hospitals or health care facility who were ventilator dependent

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

Mechanically Ventilated Patients in Medical-Surgical ICU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hassan Khouli, MD	St. Luke's-Roosevelt Hospital Center	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9142019	Background	Kollef MH, Shapiro SD, Silver P, St John RE, Prentice D, Sauer S, Ahrens TS, Shannon W, Baker-Clinkscale D. A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation. Crit Care Med. 1997 Apr;25(4):567-74. doi: 10.1097/00003246-199704000-00004.
7587255	Background