Neurological Diseases or ConditionsNCT03128086
Weaning From Mechanical Ventilation in Neurological Patients
A study testing Protocol-directed weaning in people with Neurological Diseases or Conditions, run by Hospital General Universitario de Castellón at 1 site in Spain.
Trial summary
After a period of mechanical ventilation, a spontaneous breathing trial is performed before extubation in order to assess the patient's ability to breathe. In neurological patients a spontaneous breathing trial can not predict the success of extubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases or Conditions
- What is being tested?
- Protocol-directed weaning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Acute ischemic or hemorrhagic stroke,
- Acute subarachnoid hemorrhage,
- Traumatic brain trauma,
- Metabolic encephalopathy (toxic, infectious as encephalitis or meningitis),
- Scheduled neurosurgical surgery with a prolonged mechanical ventilation
- Status epilepticus
Show all 15Show fewer
- No or minimal sedation (Propofol ≤1mg/kg/h o Midazolam ≤0,1mg/ kg/h),
- A spontaneous ventilatory stimulus,
- Absence of intracranial hypertension,
- Glasgow Coma Score > 9 (with a motor score > 4 points),
- Noradrenaline ≤ 0,2mcgr/kg/min,
- Fraction of inspired oxygen ≤ 0.5 with a positive end-expiratory pressure of 5 cmH20,
- No scheduled surgery in the next 48 hours,
- Maximal inspiratory pressure < -20cmH20
- Airway occlusion pressure at 0.1 sec >6mmHg with a support pressure of 7 cmH20 and 0 cmH20 of positive end-expiratory pressure.
Who cannot join
- Scheduled neurosurgical surgery (duration of mechanical ventilation <24 hours),
- Neuromuscular disease,
- Spinal cord injury,
- Tracheostomy,
- Inability to be evaluated,
- Severe multiple injuries evaluated by the Injury Severity Score,
Show all 9Show fewer
- Direct extubation and self-extubation,
- Patients who died during their ICU stay
- Patients transferred to another hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol-directed Weaning From Mechanical Ventilation in Neurological Patients: a Controlled Trial
After a period of mechanical ventilation, a spontaneous breathing trial is performed before extubation in order to assess the patient's ability to breathe. In neurological patients a spontaneous breathing trial can not predict the success of extubation. The extubation failure is associated with a longer intensive care unit stay and hospital stay, as well as more infections and higher mortality.
The purpose of this study is to demonstrate that the use of a protocol-directed weaning in neurological patients reduces the rate of extubation failure and associated complications.
Read the detailed description
Protocol Patients will be included in the study if they meet the following conditions: no or minimal sedation (Propofol ≤1miligram per kilogram per hour (mg/kg/h) o Midazolam ≤0,1mg/ kg/h), with a spontaneous ventilatory stimulus, absence of intracranial hypertension, Glasgow Coma Score > 9 (with a motor score > 4 points), Noradrenaline ≤ 0,2mcgr/kg/min, fraction of inspired oxygen ≤ 0.5, positive end-expiratory pressure of 5 centimeters of water (cmH20), no scheduled surgery in the next 48 hours, maximal inspiratory pressure < -20 cmH20 (means occlusion pressure test) and a airway occlusion pressure at 0.1 sec (P0.1) >6 millimeters of mercury (mmHg) with a support pressure of 7 cmH20 and 0 cmH20 of positive end-expiratory pressure.
Protocol study (study group). Spontaneous Breathing Trial (SBT). The patient will be connected to mechanical ventilation in a pressure support ventilation mode, which one will be gradually reduced (until a level de pressure support of 10 cmH20 above 5 cmH20 of positive end-expiratory pressure). After, the patient will be disconnected from the ventilator and a spontaneous breathing trial will begin through the connexion of the patient to a T-tube and a source of oxygen. Hemodynamic parameters [systolic blood pressure, heart rate], and breathing parameters [respiratory rate, partial pressure of oxygen, partial pressure of carbonic anhydrid, partial pressure of oxygen to fraction of oxygen ratio, and pH through blood gas analysis and saturation of oxyhemoglobin by pulse oximetry], and neurological (means by Glasgow Coma Score) will be collected during final period of pressure support ventilation (before disconnection) and at onset (5 minutes) and final (between 30 to 120 minutes) of spontaneous breathing trial. A once daily spontaneous breathing trial will be stablished in all the patients until they were extubated. Unsuccessful spontaneous breathing trial will be considered with more than 2 criteria: partial pressure of arterial oxygen of 50-60mmHg with fraction of inspired oxygen ≤ 0.5 (or transcutaneous pulse oximetry <90%), partial pressure of carbonic anhydride > 50 mmHg, pH <7.35, respiratory rate > 35breath per minute, heart rate > 140 beats per minute, systolic blood pressure > 180mmHg, cardiac arrhythmias during spontaneous breathing trial, dyspnea, and increased use of accessory muscles. If the SBT fails, the patient will reconnect to mechanical ventilation. A successful spontaneous breathing trial is defined as absence of whatever of variables above defined.
Airway Patency. Otherwise, if the spontaneous breathing trial is successful, the ability to maintain airway will be analyzed by the following variables: Number of aspirations of secretions/ nursing shift (No aspiration-0, 1 aspiration-1, 2 aspiration-2, ≥ 3 aspiration-3), cough capacity (Strong -0, Mild-1, Weak-2, Absent-3), Appearance and color of secretions: [Viscosity (liquid-0, frothy-1, thick-2, dry-3) and color (clear- 0, brown- 1, yellow-2, green-3)] and the presence of gag reflex (strong- 0, moderate- 1, weak- 2, absent- 3). A score ≤8 is considered as adequate to keep the permeability of airway. Then the patient will be extubated and connected to oxygen mask with fraction of inspired oxygen of 0.4. In case of extubation failure, the patient will be reintubated. The use of non-invasive ventilation is not considered in this study (neither prevention of extubation failure nor in case of extubation failure).
Conventional weaning (control group). Patients in the control group will receive weaning from mechanical ventilation according to the usual procedure, by reducing level of pressure support ventilation. Then a spontaneous breathing trial will be performed through a T-tube (the same parameters as protocol study will collected) and subsequent extubation of the patient if there is a successful spontaneous breathing trial. The criteria for spontaneous breathing trial failure and for extubation failure are the same than in the study group. In case of extubation failure, non-invasive ventilation will be not considered, but it left to the discretion of the attending physician.
- Conditions
- Neurological Diseases or Conditions
- Being tested
- Protocol-directed weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-directed weaningProcedure or surgery
Also called No other intervention
A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)
| Study group | Role | What they receive |
|---|---|---|
| Protocol-directed weaning | Experimental | A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Receives: Procedure: Protocol-directed weaning |
| Conventional weaning | No intervention | A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Extubation Failure
Rate of failure after extubation (increase of respiratory rate, deterioration of oxygenation, increase of cardiac rate or blood pressure)
Measured: 2 days after extubation
Secondary outcomes (7)
Number of Participants With Need for Tracheostomy
Need for tracheostomy during process of weaning either before or after extubation
Measured: Along intensive care unit stay (30 days)
Duration of Mechanical Ventilation
Measure all the time (in days) the patient is connected to mechanical ventilation
Measured: Intensive Care unit stay (30 days)
Intensive Care Unit Stay
Measure length of stay at intensive care unit
Measured: days (30 days)
Hospital Stay
Measure length of stay at hospital
Measured: days (2 months)
Intensive Care Unit Mortality
Mortality at intensive care unit
Measured: Along intensive care unit stay (30 days)
Hospital Mortality
Mortality at hospital (including at intensive care unit)
Measured: Along hospital stay (2 months)
90-day Mortality
Mortality at 90 days after inclusion at study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startSep 2016
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Why it stopped: Because the principal investigator has moved to another hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Castellón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALBERTO BELENGUER MUNCHARAZ, Hospital General Universitario de Castellón
- Investigators
- ALBERTO BELENGUER MUNCHARAZ, MD, Principal investigator, Hospital General Universitario de Castellón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128086
- Sponsor's protocol ID
- HGU Castellon-001
- Status last verified
- May 2020
- First submitted
- 3 Mar 2017
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Belenguer-Muncharaz A, Diaz-Tormo C, Granero-Gasamans E, Mateu-Campos ML. Protocol-directed weaning versus conventional weaning from mechanical ventilation for neurocritical patients in an intensive care unit: a nonrandomized quasi-experimental study. Crit Care Sci. 2023 Mar 1;35(1):44-56. doi: 10.5935/2965-2774.20230340-en.
PubMed 37712729
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol-directed Weaning From Mechanical Ventilation in Neurological Patients: a Controlled Trial
- ClinicalTrials.gov ID
- NCT03128086
- Acronym / sponsor ID
- HGU Castellon-001
- Conditions
- Neurological Diseases or Conditions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the principal investigator has moved to another hospital
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hospital General Universitario de CastellónUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After a period of mechanical ventilation, a spontaneous breathing trial is performed before extubation in order to assess the patient's ability to breathe. In neurological patients a spontaneous breathing trial can not predict the success of extubation. The extubation failure is associated with a longer intensive care unit stay and hospital stay, as well as more infections and higher mortality.
The purpose of this study is to demonstrate that the use of a protocol-directed weaning in neurological patients reduces the rate of extubation failure and associated complications.
Detailed description
Protocol Patients will be included in the study if they meet the following conditions: no or minimal sedation (Propofol ≤1miligram per kilogram per hour (mg/kg/h) o Midazolam ≤0,1mg/ kg/h), with a spontaneous ventilatory stimulus, absence of intracranial hypertension, Glasgow Coma Score > 9 (with a motor score > 4 points), Noradrenaline ≤ 0,2mcgr/kg/min, fraction of inspired oxygen ≤ 0.5, positive end-expiratory pressure of 5 centimeters of water (cmH20), no scheduled surgery in the next 48 hours, maximal inspiratory pressure < -20 cmH20 (means occlusion pressure test) and a airway occlusion pressure at 0.1 sec (P0.1) >6 millimeters of mercury (mmHg) with a support pressure of 7 cmH20 and 0 cmH20 of positive end-expiratory pressure.
Protocol study (study group). Spontaneous Breathing Trial (SBT). The patient will be connected to mechanical ventilation in a pressure support ventilation mode, which one will be gradually reduced (until a level de pressure support of 10 cmH20 above 5 cmH20 of positive end-expiratory pressure). After, the patient will be disconnected from the ventilator and a spontaneous breathing trial will begin through the connexion of the patient to a T-tube and a source of oxygen. Hemodynamic parameters [systolic blood pressure, heart rate], and breathing parameters [respiratory rate, partial pressure of oxygen, partial pressure of carbonic anhydrid, partial pressure of oxygen to fraction of oxygen ratio, and pH through blood gas analysis and saturation of oxyhemoglobin by pulse oximetry], and neurological (means by Glasgow Coma Score) will be collected during final period of pressure support ventilation (before disconnection) and at onset (5 minutes) and final (between 30 to 120 minutes) of spontaneous breathing trial. A once daily spontaneous breathing trial will be stablished in all the patients until they were extubated. Unsuccessful spontaneous breathing trial will be considered with more than 2 criteria: partial pressure of arterial oxygen of 50-60mmHg with fraction of inspired oxygen ≤ 0.5 (or transcutaneous pulse oximetry <90%), partial pressure of carbonic anhydride > 50 mmHg, pH <7.35, respiratory rate > 35breath per minute, heart rate > 140 beats per minute, systolic blood pressure > 180mmHg, cardiac arrhythmias during spontaneous breathing trial, dyspnea, and increased use of accessory muscles. If the SBT fails, the patient will reconnect to mechanical ventilation. A successful spontaneous breathing trial is defined as absence of whatever of variables above defined.
Airway Patency. Otherwise, if the spontaneous breathing trial is successful, the ability to maintain airway will be analyzed by the following variables: Number of aspirations of secretions/ nursing shift (No aspiration-0, 1 aspiration-1, 2 aspiration-2, ≥ 3 aspiration-3), cough capacity (Strong -0, Mild-1, Weak-2, Absent-3), Appearance and color of secretions: [Viscosity (liquid-0, frothy-1, thick-2, dry-3) and color (clear- 0, brown- 1, yellow-2, green-3)] and the presence of gag reflex (strong- 0, moderate- 1, weak- 2, absent- 3). A score ≤8 is considered as adequate to keep the permeability of airway. Then the patient will be extubated and connected to oxygen mask with fraction of inspired oxygen of 0.4. In case of extubation failure, the patient will be reintubated. The use of non-invasive ventilation is not considered in this study (neither prevention of extubation failure nor in case of extubation failure).
Conventional weaning (control group). Patients in the control group will receive weaning from mechanical ventilation according to the usual procedure, by reducing level of pressure support ventilation. Then a spontaneous breathing trial will be performed through a T-tube (the same parameters as protocol study will collected) and subsequent extubation of the patient if there is a successful spontaneous breathing trial. The criteria for spontaneous breathing trial failure and for extubation failure are the same than in the study group. In case of extubation failure, non-invasive ventilation will be not considered, but it left to the discretion of the attending physician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol-directed weaning | Experimental | Procedure: Protocol-directed weaningA protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. |
| Conventional weaning | No intervention | –A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Acute ischemic or hemorrhagic stroke,
- Acute subarachnoid hemorrhage,
- Traumatic brain trauma,
- Metabolic encephalopathy (toxic, infectious as encephalitis or meningitis),
- Scheduled neurosurgical surgery with a prolonged mechanical ventilation
Key exclusion criteria (9 listed)
- Scheduled neurosurgical surgery (duration of mechanical ventilation <24 hours),
- Neuromuscular disease,
- Spinal cord injury,
- Tracheostomy,
- Inability to be evaluated,
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 |
|---|---|---|
| Protocol-directed weaningAlso: No other interventionA protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group) | Procedure or surgery | Protocol-directed weaning |
Primary outcome
Number of Participants With Extubation Failure
Time frame: 2 days after extubation
Rate of failure after extubation (increase of respiratory rate, deterioration of oxygenation, increase of cardiac rate or blood pressure)
7 secondary outcomes
Number of Participants With Need for Tracheostomy
Time frame: Along intensive care unit stay (30 days)
Duration of Mechanical Ventilation
Time frame: Intensive Care unit stay (30 days)
Intensive Care Unit Stay
Time frame: days (30 days)
Hospital Stay
Time frame: days (2 months)
Intensive Care Unit Mortality
Time frame: Along intensive care unit stay (30 days)
Hospital Mortality
Time frame: Along hospital stay (2 months)
90-day Mortality
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37712729Belenguer-Muncharaz A, Diaz-Tormo C, Granero-Gasamans E, Mateu-Campos ML. Protocol-directed weaning versus conventional weaning from mechanical ventilation for neurocritical patients in an intensive care unit: a nonrandomized quasi-experimental study. Crit Care Sci. 2023 Mar 1;35(1):44-56. doi: 10.5935/2965-2774.20230340-en.
- Individual participant dataSharing planned: No
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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.
ALBERTO BELENGUER MUNCHARAZ, MD principal investigator
Hospital General Universitario de Castellón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol-directed weaning in people with Neurological Diseases or Conditions, run by Hospital General Universitario de Castellón at 1 site in Spain.
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 15 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 May 2020. 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 Spain. 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. 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?
Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Extubation Failure (time frame: 2 days after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128086, which also lists 1 linked publication.
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 21 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.