Weaning From Mechanical Ventilation in Neurological Patients

NCT03128086 | Terminated Results

• 1 other identifier: HGU Castellon-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Diseases or Conditions

Outcome Measures

Primary Outcomes (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)

  2 days after extubation

Secondary Outcomes (7)

• Number of Participants With Need for Tracheostomy

  Along intensive care unit stay (30 days)

• Duration of Mechanical Ventilation

  Intensive Care unit stay (30 days)

• Intensive Care Unit Stay

  days (30 days)

• Hospital Stay

  days (2 months)

• Intensive Care Unit Mortality

  Along intensive care unit stay (30 days)

Study Arms (2)

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.

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.

Interventions

Protocol-directed weaning PROCEDURE

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)

Also known as: No other intervention

Protocol-directed weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario de Castellón: lead

Study Sites (1)

Hospital General Universitario Castello

Castelló, Castellón, 12004, Spain

Location

Related Publications (1)

• 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.

  PMID: 37712729 DERIVED

Results Point of Contact

• Title: DR. ALBERTO BELENGUER-MUNCHARAZ
• Organization: HOSPITAL UNIVERSITARIO GENERAL DE CASTELLÓN, SPAIN. CONSELLERIA SANITAT

belengueralberto8@gmail.com

964 72 50 00

Study Officials

• ALBERTO BELENGUER MUNCHARAZ, MD

  Hospital General Universitario de Castellón

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: April 25, 2017
• Study Start: September 1, 2016
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)