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

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.

Study Overview

• Status: Completed
• Conditions: Weaning Failure
• Intervention / Treatment: Other: T Tube for 120 minuts; Other: Pressure Support Ventilation of 8 cmH2O for 30 minutes

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.

• Study Type: Interventional
• Enrollment (Actual): 1190
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Tracheostomy
• Non reintubation orders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: T Tube for 120 minuts; Spontaneous Breathing Trial using T Tube for 120 minutes.
Experimental: 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.	Other: Pressure Support Ventilation of 8 cmH2O for 30 minutes; Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Succesful extubation rate	Rate of succesful extubation after one of the weaning strategy	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Length of Stay	Define the ICU Length os Stay of each group	3 month
Hospital Length of Stay	Define the Hospital Length of Stay of each group	3 month
Mortality	Definte mortality rate of each group	3 month
Reintubation rate	Rate of reintubation in each group the first 72 hours	72 hours

Collaborators and Investigators

• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital General Universitario Elche; Hospital del Mar; Hospital Universitario de Canarias; Hospital Universitari de Bellvitge; Hospital General Universitario Morales Meseguer; Hospital Mutua de Terrassa; Hospital Universitario Reina Sofia de Cordoba; Hospital Universitari Joan XXIII de Tarragona.; Hospital de Granollers; Hospital de Mataró; Hospital Universitario Infanta Cristina; Consorci Sanitari de Terrassa; Hospital de Sant Joan Despí Moisès Broggi; Hospital Universitario Central de Asturias; Hospital Universitario Marqués de Valdecilla; Hospital Universitario Araba; Hospital General Universitario de Alicante; Complejo Hospitalario Universitario de Vigo; Hospital de Henares; Complejo Hospitalario Universitario de Santiago; Hospital of Navarra; Complejo Hospitalario Universitario de Badajoz; Complejo Hospitalario de Caceres; Hospital Clínico Universitario de Valencia; Hospital de Sagunto; Hospital Universitario Rey Juan Carlos; Complexo Hospitalario de Ourense; Hospital de Toledo; Hospital de Sabadell
• Investigators: Study Director: Fernandez Rafael, MD, Althaia Xarxa Assistencial Manresa

Publications and helpful links

General Publications

• 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. Erratum In: Am J Respir Crit Care Med 1997 Dec;156(6):2028.
• 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.
• 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.
• 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.
• 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. Erratum In: JAMA. 2019 Aug 20;322(7):696.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2016
• Primary Completion (Actual): March 28, 2017
• Study Completion (Actual): March 28, 2017

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Weaning; Mechanical Ventilation
• Other Study ID Numbers: CEIC 15/82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided