Post Extubation Chest Physiotherapy in ICU | NCT01967108

Studies
Post Extubation Chest Physiotherapy in ICU

NCT01967108

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

May 7, 2015Estimated

Enrollment

65Actual

Phase

Not Applicable

Conditions

Weaning From Mechanical Ventilation

Interventions

chest physiotherapy

Countries

Israel

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

Feb 2014

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 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 17, 2013

First Submission Date that Met QC Criteria

Oct 17, 2013

First Posted Date

Oct 22, 2013Estimated

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

May 6, 2015

Last Update Posted Date

May 7, 2015Estimated

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

The purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.

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

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chest physiotherapy	Experimental	chest physiotherapy in patient's bed, including deep breathing, directed cough, arm movment and more.	Other: chest physiotherapy
control group	No Intervention	This patients will not recive chest physiotherapy after extubation, unless developing respiratory deterioration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chest physiotherapy	Other	chest physiotherapy, up to one hour from extubation, in ICU patients	chest physiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
re-intubation	re-intubation up to 48 hours post extubation will be considered a weaning failure	48 hours

Secondary Outcomes

Measure	Description	Time Frame
oxygen saturation decrease		48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:ICU patients, over 18 years' old, mechanical ventilated over 24 hours, candidates for extubation -

Exclusion Criteria: Mental conditions, retardation, dementia, pregnancy, re-intubated patients

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

Name	Affiliation	Role
Enbar Foox, B.PT	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit, Rambam Health Care Campus		Haifa			Israel