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Weaning From Mechanical Ventilation in Neurological Patients

Protocol-directed Weaning From Mechanical Ventilation in Neurological Patients: a Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03128086
Enrollment
94
Registered
2017-04-25
Start date
2016-09-30
Completion date
2019-03-08
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Diseases or Conditions

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.

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.

Interventions

PROCEDUREProtocol-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)

Sponsors

Hospital General Universitario de Castellón
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Extubation Failure2 days after extubationRate of failure after extubation (increase of respiratory rate, deterioration of oxygenation, increase of cardiac rate or blood pressure)

Secondary

MeasureTime frameDescription
Duration of Mechanical VentilationIntensive Care unit stay (30 days)Measure all the time (in days) the patient is connected to mechanical ventilation
Intensive Care Unit Staydays (30 days)Measure length of stay at intensive care unit
Hospital Staydays (2 months)Measure length of stay at hospital
Number of Participants With Need for TracheostomyAlong intensive care unit stay (30 days)Need for tracheostomy during process of weaning either before or after extubation
Hospital MortalityAlong hospital stay (2 months)Mortality at hospital (including at intensive care unit)
90-day Mortality3 monthsMortality at 90 days after inclusion at study
Intensive Care Unit MortalityAlong intensive care unit stay (30 days)Mortality at intensive care unit

Countries

Spain

Participant flow

Participants by arm

ArmCount
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. 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)
50
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.
44
Total94

Baseline characteristics

CharacteristicConventional WeaningTotalProtocol-directed Weaning
Age, Categorical
<=18 years
1 Participants3 Participants2 Participants
Age, Categorical
>=65 years
20 Participants37 Participants17 Participants
Age, Categorical
Between 18 and 65 years
23 Participants54 Participants31 Participants
Age, Continuous58 years
STANDARD_DEVIATION 19
56 years
STANDARD_DEVIATION 19
54 years
STANDARD_DEVIATION 19
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Spain
44 participants94 participants50 participants
Sex: Female, Male
Female
17 Participants37 Participants20 Participants
Sex: Female, Male
Male
27 Participants57 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 509 / 44
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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)

Time frame: 2 days after extubation

Population: In conventional group, 9 participants were tracheostomized directly without previous extubation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Protocol-directed WeaningNumber of Participants With Extubation Failure8 Participants
Conventional WeaningNumber of Participants With Extubation Failure6 Participants
Secondary

90-day Mortality

Mortality at 90 days after inclusion at study

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Protocol-directed Weaning90-day Mortality6 Participants
Conventional Weaning90-day Mortality9 Participants
Secondary

Duration of Mechanical Ventilation

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

Time frame: Intensive Care unit stay (30 days)

ArmMeasureValue (MEDIAN)
Protocol-directed WeaningDuration of Mechanical Ventilation5 days
Conventional WeaningDuration of Mechanical Ventilation9 days
Secondary

Hospital Mortality

Mortality at hospital (including at intensive care unit)

Time frame: Along hospital stay (2 months)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Protocol-directed WeaningHospital Mortality5 Participants
Conventional WeaningHospital Mortality8 Participants
Secondary

Hospital Stay

Measure length of stay at hospital

Time frame: days (2 months)

ArmMeasureValue (MEDIAN)
Protocol-directed WeaningHospital Stay24 days
Conventional WeaningHospital Stay33 days
Secondary

Intensive Care Unit Mortality

Mortality at intensive care unit

Time frame: Along intensive care unit stay (30 days)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Protocol-directed WeaningIntensive Care Unit Mortality4 Participants
Conventional WeaningIntensive Care Unit Mortality3 Participants
Secondary

Intensive Care Unit Stay

Measure length of stay at intensive care unit

Time frame: days (30 days)

ArmMeasureValue (MEDIAN)
Protocol-directed WeaningIntensive Care Unit Stay9 days
Conventional WeaningIntensive Care Unit Stay14 days
Secondary

Number of Participants With Need for Tracheostomy

Need for tracheostomy during process of weaning either before or after extubation

Time frame: Along intensive care unit stay (30 days)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Protocol-directed WeaningNumber of Participants With Need for Tracheostomy4 Participants
Conventional WeaningNumber of Participants With Need for Tracheostomy11 Participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026