Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome

Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome: Comparison of Clinical Outcomes- a Retrospective Study

Tracheostomy is one of the most common procedures in the intensive care unit in patients who need prolonged invasive mechanical ventilation. There is controversy in the literature regarding the ideal timing for performing tracheostomy in critically ill patients. Early tracheostomy may be associated with a decrease in ventilation days and hospitalization. We would like to investigate whether in ventilated patients with Guillain Barre syndrome, early tracheostomy will be associated with decreased ventilation days, decreased mortality and shorter hospital and ICU length of stay.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation; Guillain Barre Syndrome
• Intervention / Treatment: Procedure: early tracheostomy (less than 7 days from intubation); Procedure: Late tracheostomy (more than 7 days from intubation)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Sara Dichtwald, MD; Phone Number: 1 972-9-7472133; Email: sara.dichtwald@clalit.org.il

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Sara Dichtwald, Dr.; Phone Number: 1 972-9-7472133; Email: sara.dichtwald@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18--99 who were admitted to the general intensive care unit from January 2012 to September 2024 with a diagnosis of Guillain-Barre syndrome who required mechanical ventilation and underwent tracheostomy during ICU stay

Description

Inclusion Criteria: All patients aged 18--99 who were admitted to the general intensive care unit from January 2012 to September 2024 with a diagnosis of Guillain-Barre syndrome who required mechanical ventilation and underwent tracheostomy during ICU stay.

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Exclusion Criteria: Missing recoreded data

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early tracheostomy; Patients with Guillain Barre who underwent early tracheostomy	Procedure: early tracheostomy (less than 7 days from intubation); Early tracheostomy (less than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome
Late tracheostomy; Patients with Guillain Barre who underwent late tracheostomy	Procedure: Late tracheostomy (more than 7 days from intubation); Late tracheostomy (more than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilation days	number of ventilation days	1 year from intubation

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Disease; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Syndrome; Guillain-Barre Syndrome
• Other Study ID Numbers: 0206-24-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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