Early Tracheostomy in Ventilated Stroke Patients

Ischemic Stroke Clinical Trial

— SETPOINT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261091
• Other study ID #: S-060/2009
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: April 23, 2014
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Stroke
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Germany	NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bösel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schönenberger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	open	No
Secondary	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.)	open	No
Secondary	Functional Outcome	This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints.	admission, discharge, at 6 months	Yes
Secondary	Mortality	This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission.	during stay, after 6 months	Yes
Secondary	Hospital Length of Stay	This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge.	open	No
Secondary	Duration of Ventilation	This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h.	open	No
Secondary	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.	Within ventilation time	No
Secondary	Time of Analgosedation Dependence	This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified.	within ICU-LOS	No
Secondary	Vasopressor Dependence	This secondary endpoint is assessed as half-days spent under vasopressors.	within ICU-LOS	No
Secondary	Time of Antibiotic Treatment	This secondary endpoint is assessed as half-days under antibiotic treatment	within ICU-LOS	No
Secondary	Pneumonias	This secondary endpoint is assessed as episodes (pre-defined by diagnostic criteria) of pneumonia.	within ICU-LOS	Yes
Secondary	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.	within ICU-LOS	Yes
Secondary	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.).	10 days post tracheostomy	Yes
Secondary	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.	within ICU-LOS	No