Ventilator WeaningVOICE-WEANINGNCT03795623
Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation
A study testing Voice-Weaning in people with Ventilator Weaning and Weaning Failure, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Weaning Failure, Brain Injuries
- What is being tested?
- Voice-Weaning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- History of psychiatric disease
- Weaning from mechanical ventilation not intended or decision to limit therapeutic interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation in Patients With Severe Brain Injury - VOICE-WEANING, a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Ventilator Weaning, Weaning Failure, Brain Injuries
- Being tested
- Voice-Weaning, Sham control
- Keywords
- Critical Illness, Respiration Disorder, Neurology
- Medical subject headings
- Brain Injuries, Critical Illness, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice-WeaningOther
Audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.
Sham controlOther
Muted audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | Sham comparator | Muted audio recordings of the patients relatives. Receives: 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. Receives: Other: Voice-Weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weaning failure
Reintubation and/or resumption of ventilatory support following extubation or death following extubation or failed spontaneous breathing trial
Measured: 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
Measured: first 28 days after start of ventilation or discharge from intensive care, whichever came first
Rate of tracheotomy
Proportion of patients requiring tracheotomy performed as percutaneous dilatative tracheotomy or surgical tracheotomy
Measured: first 28 days after start of ventilation or discharge from intensive care, whichever came first
All cause mortality rate at 90 days
Measured: first 90 days after start of ventilation
Rate of ICU delirium
Development of delirium according to the Confusion Assessment Method for intensive care unit (CAM-ICU)
Measured: first 28 days after start of ventilation or discharge from intensive care, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagen B. Huttner, University of Erlangen-Nürnberg Medical School
- Investigators
- Hagen B. Huttner, MD, PhD, Principal investigator, University of Erlangen-Nürnberg Medical School, Department of Neurology, GermanyJoji B. Kuramatsu, MD, Principal investigator, University of Erlangen-Nürnberg Medical School, Department of Neurology, GermanyMaximilian I. Sprügel, MD, Principal investigator, University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795623
- Sponsor's protocol ID
- 417_18 B
- Acronym
- VOICE-WEANING
- Status last verified
- Jan 2023
- First submitted
- 31 Dec 2018
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because of local ethics committees restrictions the final decision upon release of the raw data has not been made.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation in Patients With Severe Brain Injury - VOICE-WEANING, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03795623
- Acronym / sponsor ID
- VOICE-WEANING / 417_18 B
- Conditions
- Ventilator Weaning, Weaning Failure, Brain Injuries
- Keywords
- Critical Illness, Respiration Disorder, Neurology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | Sham comparator | Other: Sham controlMuted audio recordings of the patients relatives. |
| Voice-Weaning arm | Experimental | Other: Voice-WeaningAudio recordings of the patients relatives including information on the patient's condition and recurrent request to breath in and out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- History of psychiatric disease
- Weaning from mechanical ventilation not intended or decision to limit therapeutic interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice-WeaningAudio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge. | Other | Voice-Weaning arm |
| Sham controlMuted audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge. | Other | Conventional arm |
Primary outcome
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
4 secondary outcomes
Time of controlled ventilation
Time frame: first 28 days after start of ventilation or discharge from intensive care, whichever came first
Rate of tracheotomy
Time frame: first 28 days after start of ventilation or discharge from intensive care, whichever came first
All cause mortality rate at 90 days
Time frame: first 90 days after start of ventilation
Rate of ICU delirium
Time frame: first 28 days after start of ventilation or discharge from intensive care, whichever came first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided. Because of local ethics committees restrictions the final decision upon release of the raw data has not been made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagen B. Huttner, MD, PhD principal investigator
University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
Joji B. Kuramatsu, MD principal investigator
University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
Maximilian I. Sprügel, MD principal investigator
University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice-Weaning in people with Ventilator Weaning and Weaning Failure, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.