Guillain Barre SyndromeNCT06612242
Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome
An observational study of Guillain Barre Syndrome and Mechanical Ventilation, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain Barre Syndrome, Mechanical Ventilation
- What is being tested?
- early tracheostomy (less than 7 days from intubation) and Late tracheostomy (more than 7 days from intubation)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2025to 1 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Sara Dichtwald, Dr., 972-9-7472133 ext. 1, sara.dichtwald@clalit.org.il
About this study
Official title: 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.
- Conditions
- Guillain Barre Syndrome, Mechanical Ventilation
- Being tested
- early tracheostomy (less than 7 days from intubation), Late tracheostomy (more than 7 days from intubation)
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early tracheostomy (less than 7 days from intubation)Procedure or surgery
Early tracheostomy (less than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome
Late tracheostomy (more than 7 days from intubation)Procedure or surgery
Late tracheostomy (more than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome
| Study group | Role | What they receive |
|---|---|---|
| Early tracheostomy | Patients with Guillain Barre who underwent early tracheostomy Receives: Procedure: early tracheostomy (less than 7 days from intubation) | |
| Late tracheostomy | Patients with Guillain Barre who underwent late tracheostomy Receives: Procedure: Late tracheostomy (more than 7 days from intubation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilation days
number of ventilation days
Measured: 1 year from intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Feb 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain Barre SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612242
- Sponsor's protocol ID
- 0206-24-MMC
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided