NCT01967108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 7, 2015

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

October 17, 2013

Last Update Submit

May 6, 2015

Conditions

Weaning From Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • re-intubation

    re-intubation up to 48 hours post extubation will be considered a weaning failure

    48 hours

Secondary Outcomes (1)

  • oxygen saturation decrease

    48 hours

Study Arms (2)

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

chest physiotherapyOTHER

chest physiotherapy, up to one hour from extubation, in ICU patients

chest physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Rambam Health Care Campus

Haifa, Israel

Location

Study Officials

  • Enbar Foox, B.PT

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 22, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 7, 2015

Record last verified: 2014-02

Locations

IL(1)