Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
195 participants
INTERVENTIONAL
2009-12-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study protocol: patients will be eligible for the study after fulfilling standard criteria for weaning initiation and stratified for risk of aspiration (drink test)into two categories:
* Low/moderate risk patients (see later).
* High risk patients (spontaneous aspiration of pharyngeal secretions), will be excluded from the study.
After this evaluation patients will be randomized (concealed allocation) stratifying with the tracheostomy indication.
Weaning and Decannulation Protocol: Attempts to discontinue mechanical ventilation (MV) will be initiated when the tracheostomized patients fulfill the criteria (recovery from the precipitating illness; respiratory criteria consisting of a PaO2/fraction of inspired oxygen ratio of \>150 mm Hg with a positive end-expiratory pressure \<8 cm H2O, and an arterial pH \>7.32; and clinical criteria consisting of the absence of myocardial ischemia determined by ECG, no need for vasoactive drugs or dopamine ≤5 µg/kg/min, a heart rate \<140 beats/min, haemoglobin concentration \>8 g/dL, temperature \<38°C, no need for sedative drugs, presence of respiratory stimulus and spontaneous cough deemed clinically appropriate. Patients will be screened daily for these criteria).
A clinical algorithm for progressive weaning from mechanical ventilation will be followed at the discretion of the attending physician. Patients will be weaned following one of two methods: progressive withdrawal of pressure support ventilation or T-tube trials. When patients tolerate spontaneous breathing for 12 hours on two consecutive days, they will remain connected to the T-tube continuously.
When the patient remain disconnected from mechanical ventilation for at least 24 hours, the investigators will assess his or her preparedness for decannulation. The investigators will perform the tracheostomy tube occlusion test to exclude tracheal obstruction to airflow.
At this point, the attending physician clinically will evaluate the patient's capacity to clear respiratory secretions mainly based on the frequency of the need for suctioning and the characteristics of respiratory secretions.
The nurse will suction subglottic secretions while deflating the cuff to avoid the risk of aspiration.
Criteria for decannulation: respiratory secretions management considered adequate (\<2 aspiration every 8 hours) and low risk of aspiration.
End-points:
* Weaning time: starting the day of first disconnection (lasting \<30 minutes)and ending the day the patient is liberated from mechanical ventilation (patients will be considered weaned after 24 consecutive hours disconnected from mechanical ventilation).
* Tracheobronchitis and pneumonia after randomization. Safety considerations: The main safety concern is the risk of aspiration. First all patients will be categorized in three steps using the drink test: low risk patients (normal drink test) with no other specific interventions; moderate risk (abnormal drink test) the risk of aspiration study will include a videolaryngoscopy; high risk patients will be excluded from the study. In all patients a high flow-humidified oxygen-air mixture system will be connected trough the external cannula.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Deflating
Deflating tracheal cuff (total air suction under negative pressure using a syringe) during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support. During ventilatory support the tracheal cuff remain pressurized (30 mmHg).
Deflating tracheal cuff
Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.
Not deflating
The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support
No interventions assigned to this group
Deflating 2
Deflating tracheal cuff during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.
Deflating tracheal cuff 2
Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
Not deflating 2
The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deflating tracheal cuff
Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.
Deflating tracheal cuff 2
Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Motor component of Glasgow Coma Score \<6 points or inability to adequate manage the airway (\>2 aspirations every 8 hours).
Exclusion Criteria
* Death before starting weaning attempts.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Virgen de la Salud
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gonzalo Hernandez Martinez
FEA Medicina Intensiva
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gonzalo Hernandez, MD
Role: STUDY_CHAIR
Hospital Virgen de la Salud
Maria del Mar Cruz, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Virgen de la Salud
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Virgen de la Salud
Toledo, Toledo, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hernandez G, Pedrosa A, Ortiz R, Cruz Accuaroni Mdel M, Cuena R, Vaquero Collado C, Garcia Plaza S, Gonzalez Arenas P, Fernandez R. The effects of increasing effective airway diameter on weaning from mechanical ventilation in tracheostomized patients: a randomized controlled trial. Intensive Care Med. 2013 Jun;39(6):1063-70. doi: 10.1007/s00134-013-2870-7. Epub 2013 Mar 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
29/06/09-54
Identifier Type: -
Identifier Source: org_study_id