Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01915563
Other study ID # SBT Spain 001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date January 2015

Study information

Verified date April 2019
Source Althaia Xarxa Assistencial Universitària de Manresa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.


Description:

Intubation and mechanical ventilation are related with several complications. This increased the risk of mortality of intensive care patients. So, we always look for an early extubation when patients are recovered for the trigger disease. In spite of standardized manoeuvres to decided readiness for extubation these are not quite good because it has been described a failure extubation rate of 5% and a reintubation rate of 15%. Furthermore several risk factors has been associated with a major failure rate:>65 years old, congestive cardiac insufficiency, chronic obstructive pulmonary disease, APACHE II >12 the extubation day, BMI >30, ineffective cough, a lot of bronchial secretions (as the need for >2 endotracheal suctioning in the last 8h before extubation), failure of a previous SBT,alterations of high respiratory tract or intubation for more than 7 days.Patients without any of these factors risk has an extubation failure rate of 10% while if any of these are present extubation failure increase to 30%.

The most used technique as a weaning trial is named spontaneous breathing trial (SBT). Some physiological aspects suggest that breathing through an endotracheal tube could be a really effort trial. So our hypothesis is that a period of rest after SBT and before extubation could reduce the extubation failure rate.


Recruitment information / eligibility

Status Completed
Enrollment 470
Est. completion date January 2015
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients ventilated for more than 12h and ready to perform a SBT

Exclusion Criteria:

- patients under 18 years old,

- tracheostomy,

- excessive bronchial secretions,

- agitation,

- hypercapnia during SBT and not resuscitation orders.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
REST
After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.

Locations

Country Name City State
Spain Hospitales: Mutua de Terrassa,Médico-quirúrgico Jaen, Morales Messeguer, General de Albacete, Lorca, Málaga, Santiago, General de Catalunya, Joan XXIII Tarragona, La Fe-Valencia, Bellvitge, Moises Broggi, Mateu Orfila, Reina Sofia, Severo-Ochoa, Delfos Terrassa Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Althaia Xarxa Assistencial Universitària de Manresa

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients With Extubation Failure Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation 48 hours
Secondary ICU Mortality up to 3 months
See also
  Status Clinical Trial Phase
Completed NCT05539599 - Comprehensive Ultrasound Evaluation as a Predictor of Weaning
Completed NCT02845076 - Weaning From Noninvasive Ventilation N/A
Recruiting NCT01721434 - Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients Phase 2/Phase 3
Completed NCT01928277 - Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing N/A
Recruiting NCT05632822 - Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A
Completed NCT03240263 - Inspiratory Muscle Training in Difficult to Wean Patients N/A
Completed NCT01867853 - Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients N/A
Recruiting NCT06040138 - Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure
Completed NCT06224010 - Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
Completed NCT03129217 - The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients
Not yet recruiting NCT05431036 - Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.
Completed NCT05550220 - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients N/A
Recruiting NCT05906888 - Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes
Recruiting NCT05944588 - Predictive Value of Chest Ultrasound Observation on Extubation Failure
Not yet recruiting NCT05802745 - P0.1 and Extubation Failure in Critically Ill Patients
Recruiting NCT03894189 - The Effect of Doxapram Versus Theophylline on Diaphragmatic Function N/A
Completed NCT01877850 - Utility of a Weaning Protocol in ICU N/A
Completed NCT03580720 - Electromyography for Diaphragm Effort N/A
Recruiting NCT03880864 - Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation Phase 1