Mechanical Ventilation ComplicationNCT05295186
Non-invasive Respiratory Monitoring During SBT
An observational study of Mechanical Ventilation Complication and Acute Respiratory Failure, run by University of Bari at 2 sites in Italy.
Trial summary
Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mechanical Ventilation Complication, Acute Respiratory Failure, Re-intubation Rate
- How many people
- 238 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2022to 1 Apr 2024
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk patients for re-intubation were defined as follow : The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning >2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.
To be eligible, patients had to meet all of the following criteria:
- Age ≥ 18 years.
- The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning >2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.
- Deemed ready to be weaned from the ventilator, based on the following criteria: (a) invasive mechanical ventilation for more than 48 hours, including at least 12 hours of pressure support ventilation with PEEP ≤ 8 cmH2O and pressure support ≤ 10 cmH2O; (b) Improvement of the condition leading to intubation; (c) patient making inspiratory effort; (d) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within normal range (7.30 - 7.50); (e) Glasgow Coma Score higher than 13; (f) a core temperature below 38°C; (g) Richmond agitation and sedation scale between -1 and +1.
Eligibility required readiness for scheduled extubation after successfully completing a 30-minute SBT in the pressure-support mode (7 cmH₂O)
SBT success was defined by the following criteria [19]: (a) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within the normal range (7.30 - 7.50); (b) respiratory rate < 35/min; (c) spontaneous tidal volume higher than 5 ml of predicted body weight (PBW); (d) a ratio of respiratory rate to tidal volume (i.e. the rapid shallow breathing index, RSBI) < 105/min per liter; (e) systolic blood pressure between 90 and 160 mmHg and heart rate < 140/min, with or without low doses of vasopressors (< 0.5 mcg/kg/min). Exclusion criteria were tracheostomy, patients undergoing withdrawal of life-sustaining treatments, known neuromuscular diseases.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliero Universitaria Policlinico
Bari, 70124
Salvatore Grasso
Bari, 70124
About this study
Official title: Noninvasive Assessment of Respiratory Mechanics, Inspiratory Effort, and Respiratory Drive During Spontaneous Breathing Trial to Predict Extubation Failure in High-Risk Patients
Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Currently, non-invasive techniques allow comprehensive bedside assessment of advanced respiratory mechanics, including metrics of respiratory system compliance (CRS), respiratory muscle effort (POCC) and respiratory drive intensity (P0.1). This study investigates whether these measurements during SBT may improve the prediction of extubation outcomes
- Keywords
- spontaneous breathing trial, Extubation failure, lung mechanics, airway occlusion pressure, noninvasive monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients at high-risk for re-intubation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance Respiratory mechanics assessment during SBT
The primary endpoint was to establish whether changes in CRS, POCC and P0.1 and/or their absolute values at the end of the PAV+ SBT differed between patients who subsequently required reintubation vs. those who were successfully extubated
Measured: 30 minutes
Secondary outcomes (1)
discriminatory power
we aimed to test the discriminatory power of the absolute values of CRS, POCC and P0.1 at the end of SBT and discriminatory power of the SBT-induced percentage changes in these measurements during the trial in identifying patients who failed extubation.The decision to reintubate was made by the attending physicians, who were unaware of the study measurements results.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara, Catholic University of the Sacred Heart, Università degli Studi di Sassari, University of Turin, Italy
- Responsible party
- Principal investigator, Salvatore Grasso, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295186
- Sponsor's protocol ID
- SBT_PAV01
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murgolo F, Spadaro S, Grieco DL, Bertoni M, Pisani L, Spinazzola G, Di Mussi R, Michi T, Bartolomeo N, Fanelli V, Terragni P, Antonelli M, Ranieri VM, Grasso S. Assessment of Respiratory Mechanics and Inspiratory Effort During Spontaneous Breathing Trials to Predict Extubation Failure in High-Risk Patients. Am J Respir Crit Care Med. 2025 Dec;211(12):2340-2351. doi: 10.1164/rccm.202503-0544OC.
PubMed 41072398
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Respiratory Mechanics, Inspiratory Effort, and Respiratory Drive During Spontaneous Breathing Trial to Predict Extubation Failure in High-Risk Patients
- ClinicalTrials.gov ID
- NCT05295186
- Acronym / sponsor ID
- SBT_PAV01
- Keywords
- spontaneous breathing trial, Extubation failure, lung mechanics, airway occlusion pressure, noninvasive monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara, Catholic University of the Sacred Heart, Università degli Studi di Sassari, University of Turin, Italy
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- 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.
Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Currently, non-invasive techniques allow comprehensive bedside assessment of advanced respiratory mechanics, including metrics of respiratory system compliance (CRS), respiratory muscle effort (POCC) and respiratory drive intensity (P0.1). This study investigates whether these measurements during SBT may improve the prediction of extubation outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at high-risk for re-intubation | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk patients for re-intubation were defined as follow : The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning >2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Advance Respiratory mechanics assessment during SBT
Time frame: 30 minutes
The primary endpoint was to establish whether changes in CRS, POCC and P0.1 and/or their absolute values at the end of the PAV+ SBT differed between patients who subsequently required reintubation vs. those who were successfully extubated
1 secondary outcome
discriminatory power
Time frame: 72 hours
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 5 Mar 2025.
- Derived from this study: PubMed 41072398Murgolo F, Spadaro S, Grieco DL, Bertoni M, Pisani L, Spinazzola G, Di Mussi R, Michi T, Bartolomeo N, Fanelli V, Terragni P, Antonelli M, Ranieri VM, Grasso S. Assessment of Respiratory Mechanics and Inspiratory Effort During Spontaneous Breathing Trials to Predict Extubation Failure in High-Risk Patients. Am J Respir Crit Care Med. 2025 Dec;211(12):2340-2351. doi: 10.1164/rccm.202503-0544OC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Acute Respiratory Failure, run by University of Bari at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Advance Respiratory mechanics assessment during SBT (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295186, which also lists 1 linked publication.
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 5 Mar 2025.