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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01693705
First received: September 20, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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 Intervention
Respiratory Insufficiency
Procedure: Tracheostomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Number of patients with tracheostomy due to respiratory failure who died [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care


Estimated Enrollment: 55
Study Start Date: October 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01693705     History of Changes
Other Study ID Numbers: 0053-12-HYMC
Study First Received: September 20, 2012
Last Updated: September 24, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Tracheostomy

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014