Clinical Trials Logo

Clinical Trial Summary

Background:

One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).

Sustained restricted vigilance and impaired consciousness after ICH is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care.

Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation.

Basic hypothesis:

Compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have:

- shorter cumulative time of mechanical ventilation

- less incidence of ventilator-associated pneumonia

- less consumption of sedative drugs

- shorter duration of stay in neurocritical care unit

Randomization:

Consecutive eligible patients are randomly assigned to Either "early" tracheostomy within 72h after hospital admission Or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic tracheostomy


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01176214
Study type Interventional
Source University of Erlangen-Nürnberg Medical School
Contact
Status Terminated
Phase Phase 2
Start date July 2010
Completion date April 2014

See also
  Status Clinical Trial Phase
Recruiting NCT05089331 - ROSE-Longitudinal Assessment With Neuroimaging
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT04522102 - Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase Phase 3
Terminated NCT04178746 - PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Not yet recruiting NCT03956485 - Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
Enrolling by invitation NCT02920645 - Multicenter Validation of the AVICH Score N/A
Recruiting NCT02625948 - Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign Phase 2
Completed NCT02478177 - Addressing Real-world Anticoagulant Management Issues in Stroke
Completed NCT01971359 - Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study N/A
Completed NCT01261091 - Early Tracheostomy in Ventilated Stroke Patients N/A
Terminated NCT00990509 - Albumin for Intracerebral Hemorrhage Intervention Phase 2
Completed NCT00716079 - The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial N/A
Recruiting NCT00222625 - rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets Phase 2
Recruiting NCT05095857 - The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury Phase 4
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Not yet recruiting NCT06429332 - International Care Bundle Evaluation in Cerebral Hemorrhage Research Phase 4
Recruiting NCT05492474 - Cranial Ultrasound for Prehospital ICH Diagnosis N/A
Not yet recruiting NCT05502874 - Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Recruiting NCT04604587 - MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA Phase 3
Recruiting NCT05504941 - Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage N/A