Clinical trial NCT03795623: Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation
Official title: Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation in Patients With Severe Brain Injury - VOICE-WEANING, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Weaning Failure
Brain Injuries
Keywords: Critical Illness
Respiration Disorder
Neurology
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Methods: Adult ICU-patients with controlled mechanical ventilation ≥48h due to a neurological disease will be included in the intensive care unit. A predefined text - including information on the patient's condition and recurrent request to breath in and out - will be recorded as an audio file by one of the patient's relatives. Patients will be randomly assigned in a 1:1 ratio to the conventional treatment arm or the Voice-Weaning arm. In the conventional arm, audio recordings will be muted by an independent person resulting in a mute recording without audio signals.

When conversion from controlled to assisted mechanical ventilation is intended according to standard treatment, audio recordings will be administered in repeat mode for 10 minutes and performed three times per day. If spontaneous breathing trials (SBT) are intended according to standard treatment, the audio recordings will be played during the SBT three times per day.

Criteria for weaning not to be intended - according to Boles et al. (Weaning from mechanical ventilation. Eur Respir J. 2007) and adapted to neurological patients:

Objective measurements:

* Unstable clinical condition

  * Cardiovascular status (fC≥140/min, systolic BP \<90mmHg or \>180mmHg, more than minimal vasopressors)
  * Metabolic status (e.g. inacceptable electrolytes)
* Inadequate oxygenation

  * SaO2 ≤90% on FiO2 \>40% or pO2/FiO2 \<150mmHg or pO2/FiO2 \<120mmHg in case of chronic hypoxemia (Horowitz index)
  * PEEP\>8cmH2O
* Inadequate pulmonary function

  * fR ≥35/min
  * MIP\>(-20 -) -25cmH2O
  * VT ≤5ml/kgKG
  * VC ≤10ml/kgKG
  * fR/VT ≥105 breaths/min x l (RSBI)
  * significant respiratory acidosis (pH≤7.25)
* Unstable neurological condition

  * sedation or inadequate mentation on sedation
  * present or anticipated intracranial mass effect (e.g. midline shift \>10mm or progression, basal cistern effacement or oculomotor disturbance, signs of transfalxial/transtentorial/transforaminal herniation
  * elevation of intracranial pressure (\>20 cmH2O) and/or obstructive hydrocephalus
  * severe vasospasms (\>6 kHz in transcranial Doppler, or determined by CT-A/CT-P)
  * status epilepticus (determined by EEG)
  * acute intracranial infection (without established and/or treated origin)

Clinical assessment:

* Inadequate cough
* Excessive tracheobronchial secretion
* Disease acute phase for which the patient was intubated

Ethics Approval: The Institutional Review Board of the Friedrich-Alexander-Universität Erlangen-Nürnberg approved of the study on 13 November 2018.

Sample Size Calculation: The sample size is computed with 80% power and a 5% α-risk for the hypothesis of Voice Weaning achieving a 15% absolute weaning failure reduction. The sample size is increased by 10% to correct for dropouts and lost to follow up: a maximum of 354 patients will be included and an interim analysis be performed after inclusion of 50% of the calculated subjects.

Eligibility 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

Primary outcomes:
measure: Rate of weaning failure
timeFrame: first 28 days after start of ventilation, or until 48 hours after extubation, or discharge from intensive care, whichever came first
Secondary outcomes:
measure: Time of controlled ventilation
timeFrame: first 28 days after start of ventilation or discharge from intensive care, whichever came first
measure: Rate of tracheotomy
timeFrame: first 28 days after start of ventilation or discharge from intensive care, whichever came first
measure: All cause mortality rate at 90 days
timeFrame: first 90 days after start of ventilation
measure: Rate of ICU delirium
timeFrame: first 28 days after start of ventilation or discharge from intensive care, whichever came first
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Giessen
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
name: Hagen B. Huttner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
name: Joji B. Kuramatsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
name: Maximilian I. Sprügel, MD
role: PRINCIPAL_INVESTIGATOR
References: