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Early Tracheostomy in Ventilated Stroke Patients 2

NCT02377167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2020-11-04

No results posted yet for this study

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. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.

Conditions

  • Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage

Interventions

PROCEDURE

Tracheostomy

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

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University Hospital Heidelberg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-01-31
Completion
2020-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02377167 on ClinicalTrials.gov