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NCT01693705 Clinical Trial

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

Respiratory Insufficiency Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01693705
Other study ID # 0053-12-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 20, 2012
Last updated September 24, 2012
Start date October 2012
Est. completion date April 2013

Study information
Verified date September 2012
Source Hillel Yaffe Medical Center
Contact Boris Isakovich, MD
Phone 972-4-6304460
Email borisi@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 55
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Mechanically ventilated critical care patients

Exclusion Criteria:

- All others

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Tracheostomy

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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