Utility of a Weaning Protocol in ICU

NCT01877850 | Completed DMC

• 1 other identifier: NPn1351
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weaning Failure

Outcome Measures

Primary Outcomes (1)

• duration of weaning

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

Secondary Outcomes (1)

• duration of mechanical ventilation

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

Other Outcomes (2)

• ICU length of stay

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

• success of weaning

  spontaneous breathing for 48 hours

Study Arms (2)

case

patients with BPAW-M more than 15 or between 10 and 15, but with Tobin \<100 will be weaned with the weaning protocol by nurses

Procedure: weaning protocol

control

patients with any BWAP-M will be weaned by clinical judgment of physicians

Interventions

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.

case

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

difficult to wean patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ELENA PELI,MD: lead

Study Sites (1)

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

Brescia, Brescia, 25128, Italy

Location

Study Officials

• Elena Peli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dirigente medico

Study Record Dates

• First Submitted: June 1, 2013
• First Posted: June 14, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

IT (1)