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Completed

NCT Number: NCT01915563

Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, 08221, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REST

Procedure

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

Primary outcomes

  1. Number of Patients With Extubation Failure

    Time frame: 48 hours

    Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation

Secondary outcomes

  1. ICU Mortality

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Registry information

Official study title

Phase 2 Study of 60-min Rest After Successful Spontaneous Breathing Trial Before Extubation as a Tool for Reduction Post-extubation Failure.

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 5, 2013
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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