Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation

NCT03795623 | Completed

• 1 other identifier: 417_18 B
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Weaning; Weaning Failure; Brain Injuries

Keywords

Critical Illness; Respiration Disorder; Neurology

Outcome Measures

Primary Outcomes (1)

• Rate of weaning failure

  Reintubation and/or resumption of ventilatory support following extubation or death following extubation or failed spontaneous breathing trial

  first 28 days after start of ventilation, or until 48 hours after extubation, or discharge from intensive care, whichever came first

Secondary Outcomes (4)

• Time of controlled ventilation

  first 28 days after start of ventilation or discharge from intensive care, whichever came first

• Rate of tracheotomy

  first 28 days after start of ventilation or discharge from intensive care, whichever came first

• All cause mortality rate at 90 days

  first 90 days after start of ventilation

• Rate of ICU delirium

  first 28 days after start of ventilation or discharge from intensive care, whichever came first

Study Arms (2)

Conventional arm

SHAM COMPARATOR

Muted audio recordings of the patients relatives.

Other: Sham control

Voice-Weaning arm

EXPERIMENTAL

Audio recordings of the patients relatives including information on the patient's condition and recurrent request to breath in and out.

Other: Voice-Weaning

Interventions

Voice-Weaning OTHER

Audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.

Voice-Weaning arm

Sham control OTHER

Muted audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.

Conventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Giessen

Giessen, Germany

Location

MeSH Terms

Conditions

Brain Injuries; Critical Illness; Respiration Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 8, 2019
• Study Start: February 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: April 30, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

DE (1)