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Ischemic StrokeSETPOINTNCT01261091

Early Tracheostomy in Ventilated Stroke Patients

A study testing Early Tracheostomy and Late Tracheostomy in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Early Tracheostomy and Late Tracheostomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGermany
Study dates
Sep 2009to Apr 2012
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • age > 18 years
  • informed consent from legal representative
  • non-traumatic cerebrovascular disease
  • Estimated ventilation need for at least 2 weeks

Who cannot join

  • age < 18 years
  • informed consent not obtainable
  • intubated for more than 3 days
  • death within 3 weeks likely
  • severe chronic pulmonary disease
  • severe chronic cardiac disease
Show all 13Show fewer
  • emergency situation
  • intracranial pressure difficult to control
  • need for a permanent tracheostoma
  • contraindications for dilatative tracheostomy
  • severe coagulopathy
  • severe respiration difficulties
  • intubation/extubation/tube exchange difficulties

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg

    Heidelberg, D-69120

Other trials in Germany

About this study

Official title: Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial

Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. This study investigates the potential benefits of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic stroke.

Read the detailed description

Background: Tracheostomy is a common procedure in critical care patients. Advantages of a short tracheal tube compared to a long orotracheal one are the avoidance of laryngeal lesions and sinusitis, facilitation of nursing care and physiotherapy and the reduction of analgosedatives. The optimal point in time for tracheostomy is still unknown, but it is commonly done not later than 2-3 weeks and after one or several failed extubation trials. Studies in different sets of critical care patients have suggested additional advantages of early tracheostomy: less pneumonias and other complications, more patient comfort, less analgosedation, shorter duration of ventilation and of ICU stay. These questions have not been looked at in non-traumatic neurocritical care patients, although these might have a special weaning benefit by early tracheostomy, being mainly compromised in securing their airway, but not in breathing.

Method: Non-traumatic Neurocritical care patients with ischemic strokes, intracerebral hemorrhage or subarachnoid hemorrhage so severly affected that 2 weeks of ventilation need are estimated, are principally eligible for the study. After randomization, one group receives tracheostomy within the first 3 days after intubation. The other group stays orotracheally intubated and is either weaned and extubated or receives tracheostomy within 7 to 14 days after intubation. Tracheostomy is done as percutaneous dilatation by neurologists.

Being tested
Early Tracheostomy, Late Tracheostomy
Keywords
Neurocritical Care, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Tracheostomy, Tracheotomy, Percutaneous Dilatative Tracheostomy, Weaning, Ventilation
Medical subject headings
Ischemic Stroke, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early TracheostomyProcedure or surgery

    Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.

  • Late TracheostomyProcedure or surgery

    Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.

Study groups in NCT01261091
Study groupRoleWhat they receive
Early TracheostomyExperimentalPatients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation.
Receives: Procedure: Early Tracheostomy
Prolonged IntubationActive comparatorPatients randomized to this arm will be tried to wean off the ventilator and get (an) extubation trial(s) if regarded feasible. In case of failure or non-feasibility, they receive tracheostomy between days 7 to 14 from intubation.
Receives: Procedure: Late Tracheostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensive Care Unit Length of Stay (ICU-LOS)

    The primary endpoint is assessed as days from admission to until discharge from the intensive care unit.

    Measured: open

Secondary outcomes (13)

  1. Time of ICU-dependence

    This secondary endpoint is assessed as days from admission to a pre-defined status that would allow discharge from ICU (absence of active infection, vasopressors, pulmonary and cardial instability etc.)

    Measured: open

  2. Functional Outcome

    This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints.

    Measured: admission, discharge, at 6 months

  3. Mortality

    This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission.

    Measured: during stay, after 6 months

  4. Hospital Length of Stay

    This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge.

    Measured: open

  5. Duration of Ventilation

    This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h.

    Measured: open

  6. Duration and Quality of Weaning

    This secondary endpoint is assessed as half-days spent under the possible application of a weaning protocol, and spent within specific phases of such a protocol.

    Measured: Within ventilation time

  7. Time of Analgosedation Dependence

    This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified.

    Measured: within ICU-LOS

  8. Vasopressor Dependence

    This secondary endpoint is assessed as half-days spent under vasopressors.

    Measured: within ICU-LOS

  9. Time of Antibiotic Treatment

    This secondary endpoint is assessed as half-days under antibiotic treatment

    Measured: within ICU-LOS

  10. Pneumonias

    This secondary endpoint is assessed as episodes (pre-defined by diagnostic criteria) of pneumonia.

    Measured: within ICU-LOS

  11. Occurrence and Duration of Sepsis

    This secondary endpoint is assessed as the number of episodes and duration of sepsis as pre-defined by diagnostic criteria.

    Measured: within ICU-LOS

  12. Number and type of complications associated with the procedure

    This secondary endpoint is assessed as the number and types of complications arelated to tracheostomy (i.e. bleeding, mispositioning, malfunction, replacement demand,etc.).

    Measured: 10 days post tracheostomy

  13. Cost of Treatment

    This secondary endpoint is assessed as the total ICU-costs etsimated by length of stay and severety-derived DRG-multiplicator of each individual patient.

    Measured: within ICU-LOS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionNov 2011
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261091
Sponsor's protocol ID
S-060/2009
Acronym
SETPOINT
Status last verified
Apr 2014
First submitted
15 Dec 2010
Last updated
24 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.

    PubMed 23204058

Questions about this trial

What is this clinical trial studying?

A study testing Early Tracheostomy and Late Tracheostomy in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensive Care Unit Length of Stay (ICU-LOS) (time frame: open). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261091, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.

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