- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315477
Characteristics of Patients Intubated for Airway Protection in the Intensive Care Unit and Timing of Tracheostomy
Characteristics of Patients Intubated for Airway Protection in the Intensive Care Unit and Timing of Tracheostomy: a Retrospective Study
Every year, approximately 10-15 patients are admitted to the general intensive care unit at our institution who have been intubated for airway protection for various reasons, the main ones being soft tissue infection of the head/neck, anaphylaxis with airway edema, oral and maxillofacial/ENT surgery with airway threat, and head/neck injury with airway threat. Some patients are successfully extubated after the acute condition that caused the need for ventilation in the first place has passed, and some require tracheostomy for reasons related to the primary disease (unresolved edema, continued infectious process, need for additional invasive interventions, etc.) or for reasons related to difficulty in respiratory weaning (poor awakening, muscle weakness, development of respiratory infection, etc.).
We would like to examine whether it is possible to characterize certain parameters in the above patient population that are associated with a higher likelihood of requiring tracheostomy during hospitalization (such as age Adult). In these cases, we may consider performing the tracheostomy earlier.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sara Dichtwald, Dr
- Phone Number: 972-9-7472133
- Email: sara.dichtwald@clalit.org.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: All patients aged 18-99 who were admitted to the intensive care unit from January 2012 to November 2025 and ventilated for airway protection for any reason.
-
Exclusion Criteria:Patients who did not meet the above criteria or patients for whom data was missing.
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients intubated due to impending airway obstruction
|
early tracheostomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subgroup of patients with highest need for tracheostomy
Time Frame: 1 year
|
Subgroup with highest precentage of tracheostomy
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MMC-0269-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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