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Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT01693705
Recruitment Status : Unknown
Verified September 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Respiratory Insufficiency Procedure: Tracheostomy

Study Design

Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : October 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with tracheostomy due to respiratory failure who died [ Time Frame: Six months ]
    Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with respiratory failure who were mechanically ventilated in the critical care unit
Criteria

Inclusion Criteria:

  • Mechanically ventilated critical care patients

Exclusion Criteria:

  • All others
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693705


Contacts
Contact: Boris Isakovich, MD 972-4-6304460 borisi@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Boris Isakovich, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01693705     History of Changes
Other Study ID Numbers: 0053-12-HYMC
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by Hillel Yaffe Medical Center:
Tracheostomy

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases