NCT01693705

Brief Summary

To determine the morbidity and mortality of patients who have undergone percutaneous tracheostomy due to respiratory failure in the critical care unit and after intensive care in the internal medicine department, including follow-up of quality of life of these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

September 20, 2012

Last Update Submit

September 24, 2012

Conditions

Respiratory Insufficiency

Keywords

Tracheostomy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with tracheostomy due to respiratory failure who died

    Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care

    Six months

Study Arms (2)

Tracheostomy Patients

Critical care patients with respiratory failure who were mechanically ventilated and who underwent tracheostomy

Procedure: Tracheostomy

Non-Tracheostomy Patients

Critical care patients with respiratory failure who were mechanically ventilated but did not undergo tracheostomy

Interventions

TracheostomyPROCEDURE
Tracheostomy Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with respiratory failure who were mechanically ventilated in the critical care unit

You may qualify if:

  • Mechanically ventilated critical care patients

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Central Study Contacts

Boris Isakovich, MD

CONTACT

972-4-6304460borisi@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

IL(1)