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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Spain1 site
  • Hospital General Universitario Castello

    Castelló, Castellón, 12004

Other trials in Spain

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.

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 groups in NCT03128086
Study groupRoleWhat they receive
Protocol-directed weaningExperimentalA 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 weaningNo interventionA 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.

  1. 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)
  1. 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)

  2. Duration of Mechanical Ventilation

    Measure all the time (in days) the patient is connected to mechanical ventilation

    Measured: Intensive Care unit stay (30 days)

  3. Intensive Care Unit Stay

    Measure length of stay at intensive care unit

    Measured: days (30 days)

  4. Hospital Stay

    Measure length of stay at hospital

    Measured: days (2 months)

  5. Intensive Care Unit Mortality

    Mortality at intensive care unit

    Measured: Along intensive care unit stay (30 days)

  6. Hospital Mortality

    Mortality at hospital (including at intensive care unit)

    Measured: Along hospital stay (2 months)

  7. 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.

  1. First posted25 Apr 2017
  2. Study startSep 2016
  3. Primary completion8 Mar 2019
  4. Study completion8 Mar 2019

Why it stopped: Because the principal investigator has moved to another hospital

Resources

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)
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
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

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.

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