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Two Opposite Strategies of Weaning From Mechanical Ventilation

Two Opposite Strategies of Weaning From Mechanical Ventilation: High Work of Breathing Versus Low Work of Breathing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02620358
Enrollment
1190
Registered
2015-12-03
Start date
2016-01-11
Completion date
2017-03-28
Last updated
2017-03-31

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

Conditions

Weaning Failure

Keywords

Mechanical Ventilation, Weaning

Brief summary

This study compares two opposite strategies of weaning from Mechanical Ventilation. One of them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2 hours. The aim of the study is to know witch one has a higher successful extubation rate.

Detailed description

The final stage of weaning from Mechanical Ventilation is known as Spontaneous Breathing Test (SBT). Some studies in the last 20 years have compared different strategies of weaning. The SBT using T-Tube versus Low Pressure Support Ventilation (PSV) for 2 hours didn't show differences in successful extubation. No difference in successful extubation rate were seen with the T-Tube for 30 or 120 minutes, or the Low PSV for 30 minutes or 2 hours For this reason the actual guidelines recommend to use T-Tube or Low PSV from 30 minutes to 2 hours with the same level of evidence. Nevertheless, no studies have compared two opposite strategies like T-Tube for 2 hours (High work of breathing) versus Low PSV for only 30 minutes (Low work of breathing). Whereas the high work of breathing approach can be more specific for detecting more fitted patients, the low work of breathing method may reduce fatigue during SBT allowing more patients to be extubated. We have designed a prospective, multicentric controlled and randomized study to compare this two opposite strategies of weaning: T-Tube for 120 minutes versus PSV 8 cmH2O for 30 minutes. When patients show weaning criteria the randomly assigned SBT will be done. We consider weaning criteria: * Adequate cough * Not too many respiratory secretions. * Primary pathology solved. * Clinical stability: Heart Rate (HR) \< 140 bpm, Systolic Blood Pressure (SBP) 90-160 mmHg. * Correct oxygenation: SatO2 \> 90% with FiO2 \< 0,4. * Correct ventilatory pattern: Respiratory rate (RR) \< 35 pm, Maximal Inspiratory Pressure (MIP) \< -20 cmH2O, Tidal volume (TV) \> 10 ml/kg, RR/TV \< 100 pm/l. * Adequate level of consciousness Patients who succeed SBT will be extubated. Patients who fail SBT will be reconnected to the ventilator in the previous modality. These patients won't be randomized in future SBT. We consider SBT failure: Subjective Index: * Neurological: Agitation or anxiety, Low level of consciousness. * Increased work of breathing: accessory muscle use, dyspnea. Objective Index: * Hypoxemia: PaO2 \< 60 mmHg or SatO2 \< 90% with FiO2 \> 50%. * Tachypnea: RR \> 35 pm. * Hemodynamic instability: HR \> 140 bpm, SBP \> 180 mmHg, Arrhythmia. Extubation failure will be registered within the first 72 hours after extubation. We consider extubation failure: * Respiratory acidosis: pH \< 7,32, PaCO2 \> 45 mmHg. * Hypoxemia: SatO2 \< 90% or PaO2 \< 60 mmHg with FiO2 \> 0,5. * Deteriorating level of consciousness, Glasgow Coma Scale \< 13. * Uncontrolled agitation. * Signs of fatigue. Treatment of extubation failure will be decided by the attending physician: Reintubation, High Flow Oxygen therapy or Non Invasive Ventilation. Reintubated patients won't be randomized in future SBT. An interim analysis will be done when half of the simple is recruited. Successful extubation will be analyzed by Kaplan-Meier survivial curves and logistic multivariable analysis with confounding variables.

Interventions

OTHERT Tube for 120 minuts

Spontaneous Breathing Trial using T Tube for 120 minutes.

OTHERPressure Support Ventilation of 8 cmH2O for 30 minutes

Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes

Sponsors

Hospital Universitario Reina Sofia de Cordoba
CollaboratorOTHER_GOV
Hospital of Navarra
CollaboratorOTHER
Hospital Universitario Marqués de Valdecilla
CollaboratorOTHER
Hospital de Toledo
CollaboratorUNKNOWN
Hospital del Mar
CollaboratorOTHER
Hospital de Mataró
CollaboratorOTHER
Hospital de Sabadell
CollaboratorOTHER
Hospital de Sant Joan Despí Moisès Broggi
CollaboratorOTHER
Consorci Sanitari de Terrassa
CollaboratorOTHER
Hospital Mutua de Terrassa
CollaboratorOTHER
Hospital Universitari Joan XXIII de Tarragona.
CollaboratorOTHER
Hospital General Universitario de Alicante
CollaboratorOTHER
Hospital General Universitario Elche
CollaboratorOTHER
Hospital Clínico Universitario de Valencia
CollaboratorOTHER
Complejo Hospitalario Universitario de Badajoz
CollaboratorOTHER
Complejo Hospitalario Universitario de Santiago
CollaboratorOTHER
Complexo Hospitalario de Ourense
CollaboratorOTHER
Complejo Hospitalario Universitario de Vigo
CollaboratorOTHER
Hospital de Henares
CollaboratorOTHER
Hospital General Universitario Gregorio Marañon
CollaboratorOTHER
Hospital Universitario Rey Juan Carlos
CollaboratorOTHER
Hospital Universitario Infanta Cristina
CollaboratorOTHER
Hospital Universitario Central de Asturias
CollaboratorOTHER
Hospital General Universitario Morales Meseguer
CollaboratorOTHER
Hospital Universitario Araba
CollaboratorOTHER
Hospital Universitario de Canarias
CollaboratorOTHER
Complejo Hospitalario de Caceres
CollaboratorOTHER
Hospital de Sagunto
CollaboratorOTHER
Hospital de Granollers
CollaboratorOTHER
Hospital Universitari de Bellvitge
CollaboratorOTHER
Althaia Xarxa Assistencial Universitària de Manresa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* More tan 18 years old * More tan 24 hour of Mechanical Ventilation ready for weaning

Exclusion criteria

* Tracheostomy * Non reintubation orders

Design outcomes

Primary

MeasureTime frameDescription
Succesful extubation rate72 hoursRate of succesful extubation after one of the weaning strategy

Secondary

MeasureTime frameDescription
ICU Length of Stay3 monthDefine the ICU Length os Stay of each group
Hospital Length of Stay3 monthDefine the Hospital Length of Stay of each group
Mortality3 monthDefinte mortality rate of each group
Reintubation rate72 hoursRate of reintubation in each group the first 72 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026