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

NCT06612242 | Recruiting

• 1 other identifier: 0206-24-MMC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Guillain Barre Syndrome; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• ventilation days

  number of ventilation days

  1 year from intubation

Study Arms (2)

Early tracheostomy

Patients with Guillain Barre who underwent early tracheostomy

Procedure: early tracheostomy (less than 7 days from intubation)

Late tracheostomy

Patients with Guillain Barre who underwent late tracheostomy

Procedure: Late tracheostomy (more than 7 days from intubation)

Interventions

early tracheostomy (less than 7 days from intubation) PROCEDURE

Early tracheostomy (less than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome

Early tracheostomy

Late tracheostomy (more than 7 days from intubation) PROCEDURE

Late tracheostomy (more than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome

Late tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Dichtwald, MD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IL (1)