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

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ClinicalTrials.gov Identifier: NCT03400904
Recruitment Status : Unknown
Verified January 2018 by Karim ASEHNOUNE, Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Karim ASEHNOUNE, Nantes University Hospital

Tracking Information
First Submitted Date January 2, 2018
First Posted Date January 17, 2018
Last Update Posted Date January 18, 2018
Estimated Study Start Date May 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2018)
  • Extubation success [ Time Frame: Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal ]
    Successful removal of endo-tracheal tube
  • Extubation success [ Time Frame: Extubation failure will be defined as the need to re-intubate the patient within 96hours after removal ]
    Successful removal of endo-tracheal tube
  • Extubation success [ Time Frame: Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal ]
    Successful removal of endo-tracheal tube
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 9, 2018)
  • In-ICU VAP [ Time Frame: Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days) ]
    Ventilator-acquired pneumonia (VAP)
  • Mechanical ventilation duration [ Time Frame: ICU-stay (Median 15 days) ]
    Calculation of the duration of Mechanical Ventilation during ICU stay.
  • Tracheostomy [ Time Frame: ICU stay (Median 15 days) ]
    Study the rate and reasons for tracheostomy in patients with brain injury
  • In-ICU mortality [ Time Frame: During ICU stay (Median 15 days) ]
    Death in the ICU
  • In-hopsital mortality [ Time Frame: During the first hospital stay following Brain-Injury (Median 25 days) ]
    Death during hospitalization
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
Official Title Gestion du Sevrage de la Ventilation mécanique du Patient neurolésé en réanimation et Association Avec le Devenir. Etude Observationnelle Multi-centrique Internationale. Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome. The International Observational ENIO Study.
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing significant brain injury, with a mechanical ventilation duration≥ 24 hours and baseline Gasgow coma score ≤12, undergoing an attempt of extubation and/or tracheostomy
Condition Brain Injuries
Intervention Other: Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy
Extubation and/or tracheostomy if applicable
Study Groups/Cohorts Not Provided
Publications * Cinotti R, Pelosi P, Schultz MJ, Aikaterini I, Alvarez P, Badenes R, Mc Credie V, Elbuzidi AS, Elhadi M, Godoy DA, Gurjar M, Haenggi M, Kaye C, Mijangos-Méndez JC, Piagnerelli M, Piracchio R, Reza ST, Stevens RD, Yoshitoyo U, Asehnoune K; ENIO Study Group. Extubation strategies in neuro-intensive care unit patients and associations with outcomes: the ENIO multicentre international observational study. Ann Transl Med. 2020 Apr;8(7):503. doi: 10.21037/atm.2020.03.160.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 9, 2018)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years' old
  • Patients admitted in a ICU for a central neurological pathology, listed as follows, with estimated or clinically evaluated Glasgow Coma Score ≤12 before endo-tracheal intubation, with anomaly on brain CT-scan and requiring effective invasive mechanical ventilation ≥ 24 hours are eligible to the study:
  • Traumatic Brain Injury
  • Aneurysmal Subarachnoid haemorrhage
  • Intra-Cranial Haemorrhage
  • Ischemic Stroke
  • Central Nervous System Infection (Abscess, Empyema, Meningitides, Encephalitis…)
  • Brain Tumour
  • Patient with an attempt of extubation and/or performance of a tracheostomy

Exclusion Criteria:

  • Patients < 18 years' old
  • Patients with ongoing pregnancy
  • Patients with spine cord injury above T4
  • Resuscitated cardiac arrest
  • Withdrawal of Life-Sustaining Treatment (WLST) in the first 24 hours
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03400904
Other Study ID Numbers RC17_0328
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All proposals for sub-studies on the main ENIO database are encouraged. Secondary studies must be approved by the steering committee. Study results will be presented and disseminated in a timely manner. Authorship will be proposed by the investigators of the sub-studies and approved by the steering committee. National groups may enter requests for data-access to analyse their national datasets. Owing to the full anonymization of data according to European Union laws and regulations, institutional datasets will not be available.
Time Frame: No time limit
Responsible Party Karim ASEHNOUNE, Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date January 2018