Characteristics of Patients Intubated for Airway Protection in the Intensive Care Unit and Timing of Tracheostomy

NCT07315477 | Not Yet Recruiting

• 1 other identifier: MMC-0269-25
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Airway Clearance Impairment; Intubating Conditions

Outcome Measures

Primary Outcomes (1)

• Subgroup of patients with highest need for tracheostomy

  Subgroup with highest precentage of tracheostomy

  1 year

Study Arms (1)

Patients intubated due to impending airway obstruction

Procedure: early tracheostomy

Interventions

early tracheostomy PROCEDURE

early tracheostomy

Patients intubated due to impending airway obstruction

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Central Study Contacts

Sara Dichtwald, Dr

CONTACT

972-9-7472133; sara.dichtwald@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share