NCT03512054

Brief Summary

Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury). However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily. This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

March 23, 2018

Last Update Submit

December 22, 2020

Conditions

TracheostomyBrain Injuries

Keywords

TracheostomyDecannulationRehabilitationBrain injuryNeurosurgery

Outcome Measures

Primary Outcomes (1)

  • Number of safe decannulation

    The main objective is to determine the effectiveness of the standardized 5-step weaning procedure for selecting patients to be decannulated without failure. This is measured by the proportion of safe decannulation for all decannulated tracheotomised patients included in the study. The failure of decannulation is defined by a recannulation within 96h.

    Up to 3 month after weaning procedure start (Inclusion)

Secondary Outcomes (5)

  • Reasons of failure in weaning process

    Up to 3 month after weaning procedure start (Inclusion)

  • Life threatening event occurrence during the weaning procedure

    Up to 3 month after weaning procedure start (Inclusion)

  • Mortality at 6 months

    6 month after weaning procedure start (Inclusion)

  • Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore

    Up 6 month after weaning procedure start (Inclusion)

  • Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score

    Up 6 month after weaning procedure start (Inclusion)

Study Arms (1)

Experimental procedure

EXPERIMENTAL
Procedure: Standardized 5-step weaning procedure

Interventions

Standardized 5-step weaning procedurePROCEDURE

Weaning process in 5 steps (0-4), by a multi-professional team (neurosurgeon, physiotherapist, nurse, caregiver…) Stability criteria are defined for each person, after validation pass the next step. Stability criteria degradation return to the previous step. Weaning process can take back after stability criteria renormalization. Step 0: cuff deflate. Step 1: occlusion test. Steps 0 and 1 can assess the freedom and protect capacity airway. In failure process, we can propose a nasofibroscopy. Step 2: Phonatory Valve. Respiratory rehabilitation/ swallowing, limiting breathing effort. The valve ought to stay 12 hours before going to the step 3. Step 3: Plug. Finish the Respiratory rehabilitation/ swallowing. The plug ought to stay 24hours minimum before going to the step 4. Step 4: Decannulation

Experimental procedure

Eligibility Criteria

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

You may qualify if:

  • age at least 18 years old
  • brain-injury disease
  • tracheotomy act while in neurosurgery or reanimation stay
  • no artificial ventilation
  • medical cover

You may not qualify if:

  • Malnutrition (defines by the age) :
  • age \< 70 years old: body mass index (B.D.I.) \<16 kg/m² or albuminemia \<20 g/L
  • age \> 70 years old: body mass index (B.D.I.) \<18 kg/m² or albuminemia \<30 g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Eric FRISON, MD

    Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 30, 2018

Study Start

June 20, 2018

Primary Completion

December 24, 2019

Study Completion

December 18, 2020

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)