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Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation (VOICE-WEANING)

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ClinicalTrials.gov Identifier: NCT03795623
Recruitment Status : Suspended (Only recruitment temporarily paused due to Covid-19)
First Posted : January 8, 2019
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hagen B. Huttner, University of Erlangen-Nürnberg Medical School

Brief Summary:

Patients with severe brain injuries, such as ischemic stroke and intracranial hemorrhage, frequently require mechanical ventilation. Weaning of stroke patients is complicated by impaired consciousness and respiratory drive. Higher rates of weaning failure and delayed extubation (≥ 48h) lead to ventilator associated pneumonia, higher mortality and necessity of tracheostomy.

Therefore, improving the weaning of stroke patients from mechanical ventilation is warranted to prevent ventilator-associated complications and eventually improve clinical outcomes.

This single-center, randomized, clinical trial aims at demonstrating that voices of patients' relatives support weaning from mechanical ventilation and reduce weaning failure in brain-injured patients.


Condition or disease Intervention/treatment Phase
Ventilator Weaning Weaning Failure Brain Injuries Other: Voice-Weaning Other: Sham control Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation in Patients With Severe Brain Injury - VOICE-WEANING, a Randomized Clinical Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Sham Comparator: Conventional arm
Muted audio recordings of the patients relatives.
Other: Sham control
Muted audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.

Experimental: Voice-Weaning arm
Audio recordings of the patients relatives including information on the patient's condition and recurrent request to breath in and out.
Other: Voice-Weaning
Audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.




Primary Outcome Measures :
  1. Rate of weaning failure [ Time Frame: first 28 days after start of ventilation, or until 48 hours after extubation, or discharge from intensive care, whichever came first ]
    Reintubation and/or resumption of ventilatory support following extubation or death following extubation or failed spontaneous breathing trial


Secondary Outcome Measures :
  1. Time of controlled ventilation [ Time Frame: first 28 days after start of ventilation or discharge from intensive care, whichever came first ]
  2. Rate of tracheotomy [ Time Frame: first 28 days after start of ventilation or discharge from intensive care, whichever came first ]
    Proportion of patients requiring tracheotomy performed as percutaneous dilatative tracheotomy or surgical tracheotomy

  3. All cause mortality rate at 90 days [ Time Frame: first 90 days after start of ventilation ]
  4. Rate of ICU delirium [ Time Frame: first 28 days after start of ventilation or discharge from intensive care, whichever came first ]
    Development of delirium according to the Confusion Assessment Method for intensive care unit (CAM-ICU)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intubation and controlled mechanical ventilation ≥48h due to a neurological disease
  • Weaning from mechanical ventilation intended by the attending physician
  • Obtained informed consent from the legal representative

Exclusion Criteria:

  • Age < 18 years
  • History of psychiatric disease
  • Weaning from mechanical ventilation not intended or decision to limit therapeutic interventions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795623


Locations
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Germany
University of Erlangen-Nürnberg
Erlangen, Germany
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Hagen B. Huttner, MD, PhD University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
Principal Investigator: Joji B. Kuramatsu, MD University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
Principal Investigator: Maximilian I. Sprügel, MD University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
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Responsible Party: Hagen B. Huttner, Principal Investigator, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03795623    
Other Study ID Numbers: 417_18 B
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Because of local ethics committees restrictions the final decision upon release of the raw data has not been made.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hagen B. Huttner, University of Erlangen-Nürnberg Medical School:
Critical Illness
Respiration Disorder
Neurology
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System