Early Tracheostomy in Ventilated Stroke Patients (SETPOINT)

Heidelberg University

Status: Completed

Conditions: Subarachnoid Hemorrhage; Ischemic Stroke; Intracerebral Hemorrhage

Treatments: Procedure: Early Tracheostomy; Procedure: Late Tracheostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01261091

S-060/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Early Tracheostomy

Experimental group

Description:

Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation.

Treatment:

Procedure: Early Tracheostomy

Prolonged Intubation

Active Comparator group

Description:

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 between days 7 to 14 from intubation.

Treatment:

Procedure: Late Tracheostomy