Extubation Strategies in Neuro-Intensive Care Unit Patients & Associations

Status Completed

Clinical Trial Summary

Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain Injury (BI). Guidelines for the management of extubation are largely lacking for patients with BI, and the role of tracheostomy is highly uncertain. More important, data on practice of management of extubation is yet underreported, as is the use of tracheotomy in this specific subset of critical care patients. Objective The objective of this prospective observational study is to describe the management of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to describe the incidence of extubation failure and the rate of tracheostomy. Study design The "Extubation strategies in Neuro-Intensive care unit patients, and associations with Outcomes (ENIO)" is an observational multicentre international cohort study. Study population The investigators will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission. The inclusion period will last 6 months in total, and each centre is expected to include at least 24 patients during this period. With over 60 ICUs participating worldwide, we expect to include 1500 patients. Main parameters Parameters to be collected include: general neurological management, ventilatory management, general ICU complications, specific data on extubation and tracheostomy, general in-ICU outcomes and in-hospital mortality. Nature and extent of the burden and risks associated with participation Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts and/or (written or electronic) medical records systems bears no risk to the patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Brain Injuries

Clinical Trial Details

NCT number	NCT03400904
Study type	Observational
Source	Nantes University Hospital
Contact
Status	Completed
Phase
Start date	September 6, 2018
Completion date	January 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05542108` - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants	N/A
Completed	`NCT06073145` - Transcranial Doppler Using Wearable Ultrasound Patch
Recruiting	`NCT03899532` - Remote Ischemic Conditioning in Traumatic Brain Injury	N/A
Recruiting	`NCT06010823` - Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants	N/A
Not yet recruiting	`NCT05833568` - Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness	N/A
Withdrawn	`NCT04288076` - The Brain and Lung Interaction (BALI) Study	N/A
Completed	`NCT03162484` - Physical Activity and Chronic Acquired Brain Injury	N/A
Not yet recruiting	`NCT02756585` - Computed Tomography Perfusion in Patients With Severe Head Injury	N/A
Terminated	`NCT01430988` - Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury	N/A
Completed	`NCT01093053` - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations	N/A
Completed	`NCT00975338` - The LETS Study: A Longitudinal Evaluation of Transition Services
Completed	`NCT00878631` - Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline	Phase 2/Phase 3
Completed	`NCT03166722` - Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition	N/A
Not yet recruiting	`NCT04478812` - Tbit System Precision and Correlation of Different Blood Samples	N/A
Recruiting	`NCT05309005` - Virtual Reality and Social Cognition After Acquired Brain Injury
Recruiting	`NCT05443542` - VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI	N/A
Completed	`NCT02702635` - Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging	N/A
Withdrawn	`NCT04247321` - Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure	N/A
Not yet recruiting	`NCT04386525` - Omega 3 and Ischemic Stroke; Fish Oil as an Option	Phase 4
Completed	`NCT03636399` - Group Based Treatment for Persons With Social Communication Difficulties	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome. — ENIO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms