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: Not yet recruiting
• Conditions: Airway Clearance Impairment; Intubating Conditions
• Intervention / Treatment: Procedure: early tracheostomy

• Study Type: Observational
• Enrollment (Estimated): 200

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: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

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.

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Exclusion Criteria:Patients who did not meet the above criteria or patients for whom data was missing.

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients intubated due to impending airway obstruction	Procedure: early tracheostomy; early tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup of patients with highest need for tracheostomy	Subgroup with highest precentage of tracheostomy	1 year

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No