Two Opposite Strategies of Weaning From Mechanical Ventilation
NCT ID: NCT02620358
Last Updated: 2017-03-31
Study Results
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Basic Information
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COMPLETED
NA
1190 participants
INTERVENTIONAL
2016-01-11
2017-03-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Work of Breathing
If patient has weaning criteria, a Spontaneous Breathing Trial (SBT) with T Tube for 2 hours will be done.
The patient will be extubated after the SBT if he has no criteria of SBT failure.
T Tube for 120 minuts
Spontaneous Breathing Trial using T Tube for 120 minutes.
Low Work of Breathing
If patient has weaning criteria a Spontaneous Breathing Trial (SBT) with Pressure Support Ventilation of 8 cmH2O for 30 minutes will be done.
The patient will be extubated after the SBT if he has no criteria of SBT failure.
Pressure Support Ventilation of 8 cmH2O for 30 minutes
Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes
Interventions
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T Tube for 120 minuts
Spontaneous Breathing Trial using T Tube for 120 minutes.
Pressure Support Ventilation of 8 cmH2O for 30 minutes
Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes
Eligibility Criteria
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Inclusion Criteria
* More tan 24 hour of Mechanical Ventilation ready for weaning
Exclusion Criteria
* Non reintubation orders
18 Years
99 Years
ALL
No
Sponsors
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Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Hospital of Navarra
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Hospital de Toledo
UNKNOWN
Hospital del Mar
OTHER
Hospital de Mataró
OTHER
Hospital de Sabadell
OTHER
Hospital de Sant Joan Despí Moisès Broggi
OTHER
Consorci Sanitari de Terrassa
OTHER
Hospital Mutua de Terrassa
OTHER
Hospital Universitari Joan XXIII de Tarragona.
OTHER
Hospital General Universitario de Alicante
OTHER
Hospital General Universitario Elche
OTHER
Hospital Clínico Universitario de Valencia
OTHER
Complejo Hospitalario Universitario de Badajoz
OTHER
Complejo Hospitalario Universitario de Santiago
OTHER
Complexo Hospitalario de Ourense
OTHER
Complejo Hospitalario Universitario de Vigo
OTHER
Hospital de Henares
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario Rey Juan Carlos
OTHER
Hospital Universitario Infanta Cristina
OTHER
Hospital Universitario Central de Asturias
OTHER
Hospital General Universitario Morales Meseguer
OTHER
Hospital Universitario Araba
OTHER
Hospital Universitario de Canarias
OTHER
Complejo Hospitalario de Caceres
OTHER
Hospital de Sagunto
OTHER
Hospital de Granollers
OTHER
Hospital Universitari de Bellvitge
OTHER
Althaia Xarxa Assistencial Universitària de Manresa
OTHER
Responsible Party
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Carles Subirà Cuyàs
Physician
Principal Investigators
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Fernandez Rafael, MD
Role: STUDY_DIRECTOR
Althaia Xarxa Assistencial Manresa
References
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Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.
Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.
Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.
Other Identifiers
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CEIC 15/82
Identifier Type: -
Identifier Source: org_study_id
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