NCT02377167

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4.7 years

First QC Date

January 28, 2015

Last Update Submit

November 3, 2020

Conditions

Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Dichotomized functional outcome (a modified Rankin Scale (mRS) score of 0-4 (favorable outcome) vs 5,6 (poor outcome)) at 6 months after admission to ICU

    6 months

Secondary Outcomes (13)

  • Mortality

    6 months

  • Hospital Length of stay

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Duration of ventilation

    participants will be followed for the duration of hospital stay, an expected average of 5 weeks

  • Duration and Quality of Weaning

    participants will be followed for the duration of weaning, an expected average of 6 weeks

  • Time of Analgosedation Dependence

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • +8 more secondary outcomes

Study Arms (2)

Early Tracheostomy

EXPERIMENTAL

Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 5 days from intubation. Intervention: Procedure: Early Tracheostomy

Procedure: Tracheostomy

Prolonged Intubation

ACTIVE COMPARATOR

Patients 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 after intubation day 10. Intervention: Procedure: Late Tracheostomy

Procedure: Tracheostomy

Interventions

TracheostomyPROCEDURE

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

Early TracheostomyProlonged Intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • informed consent from legal representative
  • non-traumatic cerebrovascular disease
  • Estimated ventilation need for at least 2 weeks
  • The clinical judgement of the attending neurointensivist
  • principle indication for tracheostomy

You may not qualify if:

  • Premorbid modified Rankin Score (mRS)\>1
  • Artificial ventilation for more than 4 days
  • Severe chronic pulmonary disease requiring supplemental oxygen, or evidence of CO2 retention on admission serum analysis (HCO3≥30)
  • Severe chronic cardiac disorder
  • Any emergency situation compromising the patient's well-being or ability to undergo tracheostomy in the study time-frame
  • Intracranial pressure (ICP) persistently \> 25cmH2O
  • Difficult airway management, anticipated problems with extubation / re-intubation,
  • Need for a permanent surgical tracheostomy
  • Contraindications for a percutaneous tracheostomy (see below)
  • High oxygenation requirements: Positive end-expiratory pressure \> 12, or fraction of inspired oxygen \> 0.6)
  • Pregnancy
  • Participation in any other interventional trial
  • Life expectancy \< 3 weeks
  • Patient/family unlikely to opt for at least 3 weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHHeidelberg

Heidelberg, 69120, Germany

Location

Related Publications (3)

  • 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.

    PMID: 23204058BACKGROUND

  • Bosel J, Niesen WD, Salih F, Morris NA, Ragland JT, Gough B, Schneider H, Neumann JO, Hwang DY, Kantamneni P, James ML, Freeman WD, Rajajee V, Rao CV, Nair D, Benner L, Meis J, Klose C, Kieser M, Suarez JI, Schonenberger S, Seder DB; SETPOINT2 and the IGNITE Study Groups. Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1899-1909. doi: 10.1001/jama.2022.4798.

    PMID: 35506515DERIVED

  • Schonenberger S, Niesen WD, Fuhrer H, Bauza C, Klose C, Kieser M, Suarez JI, Seder DB, Bosel J; SETPOINT2-Study Group; IGNITE-Study Group. Early tracheostomy in ventilated stroke patients: Study protocol of the international multicentre randomized trial SETPOINT2 (Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2). Int J Stroke. 2016 Apr;11(3):368-79. doi: 10.1177/1747493015616638. Epub 2016 Jan 5.

    PMID: 26763913DERIVED

MeSH Terms

Conditions

IschemiaHemorrhagic StrokeSubarachnoid Hemorrhage

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhage

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Julian Bösel, MD

Study Record Dates

First Submitted

January 28, 2015

First Posted

March 3, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2020

Study Completion

October 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)