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Completed

NCT Number: NCT01261091

Early Tracheostomy in Ventilated Stroke Patients

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Stroke Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg

Heidelberg, D-69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Early Tracheostomy

Procedure

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

Late Tracheostomy

Procedure

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

Primary outcomes

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

    Time frame: open

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

Secondary outcomes

  1. Time of ICU-dependence

    Time frame: open

    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.)

  2. Functional Outcome

    Time frame: admission, discharge, at 6 months

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

  3. Mortality

    Time frame: during stay, after 6 months

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

  4. Hospital Length of Stay

    Time frame: open

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

  5. Duration of Ventilation

    Time frame: open

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

  6. Duration and Quality of Weaning

    Time frame: Within ventilation time

    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.

  7. Time of Analgosedation Dependence

    Time frame: within ICU-LOS

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

  8. Vasopressor Dependence

    Time frame: within ICU-LOS

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

  9. Time of Antibiotic Treatment

    Time frame: within ICU-LOS

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

  10. Pneumonias

    Time frame: within ICU-LOS

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

  11. Occurrence and Duration of Sepsis

    Time frame: within ICU-LOS

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

  12. Number and type of complications associated with the procedure

    Time frame: 10 days post tracheostomy

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

  13. Cost of Treatment

    Time frame: within ICU-LOS

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Acronym: SETPOINT

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 16, 2010
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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