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Weaning From Mechanical Ventilation in Neurological Patients

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ClinicalTrials.gov Identifier: NCT03128086
Recruitment Status : Terminated (Because the principal investigator has moved to another hospital)
First Posted : April 25, 2017
Results First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
ALBERTO BELENGUER MUNCHARAZ, Hospital General Universitario de Castellón

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Neurological Diseases or Conditions Procedure: Protocol-directed weaning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Protocol-directed Weaning From Mechanical Ventilation in Neurological Patients: a Controlled Trial
Study Start Date : September 2016
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 8, 2019

Arm Intervention/treatment
Experimental: Protocol-directed weaning
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.
Procedure: Protocol-directed weaning
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)
Other Name: No other intervention

No Intervention: Conventional weaning
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of Participants With Need for Tracheostomy [ Time Frame: Along intensive care unit stay (30 days) ]
    Need for tracheostomy during process of weaning either before or after extubation

  2. Duration of Mechanical Ventilation [ Time Frame: Intensive Care unit stay (30 days) ]
    Measure all the time (in days) the patient is connected to mechanical ventilation

  3. Intensive Care Unit Stay [ Time Frame: days (30 days) ]
    Measure length of stay at intensive care unit

  4. Hospital Stay [ Time Frame: days (2 months) ]
    Measure length of stay at hospital

  5. Intensive Care Unit Mortality [ Time Frame: Along intensive care unit stay (30 days) ]
    Mortality at intensive care unit

  6. Hospital Mortality [ Time Frame: Along hospital stay (2 months) ]
    Mortality at hospital (including at intensive care unit)

  7. 90-day Mortality [ Time Frame: 3 months ]
    Mortality at 90 days after inclusion at study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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,
  • Direct extubation and self-extubation,
  • Patients who died during their ICU stay
  • Patients transferred to another hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128086


Locations
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Spain
Hospital General Universitario Castello
Castelló, Castellón, Spain, 12004
Sponsors and Collaborators
Hospital General Universitario de Castellón
Investigators
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Principal Investigator: ALBERTO BELENGUER MUNCHARAZ, MD Hospital General Universitario de Castellón
  Study Documents (Full-Text)

Documents provided by ALBERTO BELENGUER MUNCHARAZ, Hospital General Universitario de Castellón:
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Responsible Party: ALBERTO BELENGUER MUNCHARAZ, Principal investigator, Hospital General Universitario de Castellón
ClinicalTrials.gov Identifier: NCT03128086    
Other Study ID Numbers: HGU Castellon-001
First Posted: April 25, 2017    Key Record Dates
Results First Posted: May 21, 2020
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nervous System Diseases