Two Opposite Strategies of Weaning From Mechanical Ventilation

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620358
• Other study ID #: CEIC 15/82
• Status: Completed
• Phase: N/A
• First received: November 20, 2015
• Last updated: March 30, 2017
• Start date: January 11, 2016
• Est. completion date: March 28, 2017

Study information

• Verified date: March 2017
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1190
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• More tan 18 years old

• More tan 24 hour of Mechanical Ventilation ready for weaning

Exclusion Criteria:

• Tracheostomy

• Non reintubation orders

Related Conditions & MeSH terms

• Weaning Failure

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (31)

Lead Sponsor

Collaborator

Althaia Xarxa Assistencial Universitària de Manresa

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

References & Publications (6)

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. — View Citation

Esteban A, Alía I, Gordo F, Fernández R, Solsona JF, Vallverdú I, Macías S, Allegue JM, Blanco J, Carriedo D, León M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazón E, Carrizosa F, Tomás R, Suarez J, Goldwasser RS. Extubation outcome after sponta — View Citation

Esteban A, Alía I, Tobin MJ, Gil A, Gordo F, Vallverdú I, Blanch L, Bonet A, Vázquez A, de Pablo R, Torres A, de La Cal MA, Macías S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung — View Citation

Esteban A, Anzueto A, Alía I, Gordo F, Apezteguía C, Pálizas 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. — View Citation

Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group.. Characteristics and outcomes in adult patients receiving mechanica — View Citation

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. Epub 2002 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Succesful extubation rate	Rate of succesful extubation after one of the weaning strategy	72 hours
Secondary	ICU Length of Stay	Define the ICU Length os Stay of each group	3 month
Secondary	Hospital Length of Stay	Define the Hospital Length of Stay of each group	3 month
Secondary	Mortality	Definte mortality rate of each group	3 month
Secondary	Reintubation rate	Rate of reintubation in each group the first 72 hours	72 hours