Weaning FailureWEANNCT01877850
Utility of a Weaning Protocol in ICU
An observational study of Weaning Failure, run by ELENA PELI,MD at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Weaning Failure
- What is being tested?
- weaning protocol
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: difficult to wean patients
Who may be able to join
- 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.
Who cannot join
- patients assessed as easy weaning and not tracheostomized;
- patients already tracheostomized on admission to ICU.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,
Brescia, Brescia, 25128
About this study
Official 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.
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.
Read the detailed description
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.
- Conditions
- Weaning Failure
- Being tested
- weaning protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weaning protocolProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: weaning protocol | |
| control | patients with any BWAP-M will be weaned by clinical judgment of physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of weaning
Measured: within the first 15 days (plus or minus 5 days) after start of weaning
Secondary outcomes (1)
duration of mechanical ventilation
Measured: within the first 12 days (plus or minus 10 days) after start of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ELENA PELI,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ELENA PELI,MD, Università degli Studi di Brescia
- Investigators
- Elena Peli, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877850
- Sponsor's protocol ID
- NPn1351
- Acronym
- WEAN
- Status last verified
- Apr 2015
- First submitted
- 1 Jun 2013
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01877850
- Acronym / sponsor ID
- WEAN / NPn1351
- Conditions
- Weaning Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ELENA PELI,MDUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Procedure: weaning protocolpatients with BPAW-M more than 15 or between 10 and 15, but with Tobin <100 will be weaned with the weaning protocol by nurses |
| control | – | –patients with any BWAP-M will be weaned by clinical judgment of physicians |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- difficult to wean patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- patients assessed as easy weaning and not tracheostomized;
- patients already tracheostomized on admission to ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weaning protocolReduction 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. | Procedure or surgery | case |
Primary outcome
duration of weaning
Time frame: within the first 15 days (plus or minus 5 days) after start of weaning
1 secondary outcome
duration of mechanical ventilation
Time frame: within the first 12 days (plus or minus 10 days) after start of mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Peli principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure, run by ELENA PELI,MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of weaning (time frame: within the first 15 days (plus or minus 5 days) after start of weaning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.