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Completed

NCT Number: NCT01877850

Utility of a Weaning Protocol in ICU

The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,

Brescia, 25128, Italy

About this study

All patients with prolonged weaning and who required tracheostomy are enrolled in the study. These patients are randomized as "Case or Control" by a computer program.

Patients can start the weaning process when the acute phase of the respiratory failure has been resolved and pressure support ventilation was setted.

For all this patients are calculated modified-BWAP(BWAP-M) and TOBIN indexes. The "Case" patients started the weaning protocol process only if BWAP-M value is more than 15 or BWAP-M 10-15 with Tobin index < 100.

If not, the BWAP-M and Tobin will be calculated every day. The Control patients will start weaning by clinical judgement even if the BWAP-M value is less than 10.

For all patients are calculated: the duration of weaning process, the ICU length of stay and the duration of the mechanical ventilation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU
  • improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) >200 with fraction inspired oxygen (FiO2)< 0,45.
  • pressure supported ventilation at the time of enrollment.

Exclusion criteria

  • patients assessed as easy weaning and not tracheostomized;
  • patients already tracheostomized on admission to ICU.

Treatment and study plan

Weaning protocol

Procedure

Reduction of pressure support ventilation (PSV) by 2cmH2O at a time to a maximum of 4cmH2O per day.

When a patient was able to tolerate PSV less than 8 cmH2O for at least 120 minutes, the nurses started to reduce End Expiratory Positive Pressure (PEEP) by 2cmH2O at a time to a maximum of 4cmH2O per day.

When a patient was able to tolerate PSV less than 8 cmH2O with PEEP less than 6 cmH2O, the nurses started SBT trial: Continuos Positive Pressure Airways of 6cmH2O for at least 120 minutes and following discontinuation from ventilator.

Primary outcomes

  1. duration of weaning

    Time frame: within the first 15 days (plus or minus 5 days) after start of weaning

Secondary outcomes

  1. duration of mechanical ventilation

    Time frame: within the first 12 days (plus or minus 10 days) after start of mechanical ventilation

Other outcomes

  1. ICU length of stay

    Time frame: within the first 26 days (plus or minus 22 days) after ICU recovery

  2. success of weaning

    Time frame: spontaneous breathing for 48 hours

Sponsors and collaborators

Lead sponsor

ELENA PELI,MD

Other

Registry information

Official study title

Non Pharmacological Randomized Clinical Trial Designed to Evaluate the Difference of the Duration of Weaning Process From the Ventilator Between Protocol-driven Weaned Patients and Clinical-driven Weaned Patients.

Acronym: WEAN

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2013
Registry last updated
Apr 23, 2015

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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