Early vs. Late Tracheostomy in Patients With Guillain -Ba... | NCT06612242

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

NCT06612242

Sponsor

Meir Medical Center

Status

Recruiting

Last Update Posted

May 13, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Guillain Barre Syndrome
Mechanical Ventilation

Interventions

early tracheostomy (less than 7 days from intubation)
Late tracheostomy (more than 7 days from intubation)

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Sep 23, 2024

First Submission Date that Met QC Criteria

Sep 23, 2024

First Posted Date

Sep 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2025

Last Update Posted Date

May 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Exclusion Criteria: Missing recoreded data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara Dichtwald, MD	Contact	972-9-7472133	1	sara.dichtwald@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center	Recruiting	Kfar Saba			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020275	Guillain-Barre Syndrome

Ancestor Terms

ID	Term
D011129	Polyradiculoneuropathy
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided