Weaning FailureNCT05526053
Lung Volume Preservation During Extubation
A study testing Lung volume preservation in people with Weaning Failure and Pulmonary Collapse, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial summary
Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Pulmonary Collapse
- What is being tested?
- Lung volume preservation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,753 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2023to 13 Aug 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients> 18 years who meet weaning criteria (see below)
- More than 24 hours of mechanical ventilation (MV)
- Signed Informed Consent by a substitute decision maker (SDM).
- Weaning Criteria:
- Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) < -15 cmH2O).
- Absence of excessive secretions (<3 aspirations in the last 8 hours).
Show all 11Show fewer
- Resolution or improvement of the pathology that led to intubation.
- Clinical stability (Heart Rate (HR) <140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses).
- Adequate oxygenation (SatO2> 90% with Inspiratory Fraction of oxygen (FiO2) <0.4).
- Adequate ventilatory mechanics (Respiratory rate (RR) <35 rpm, Tidal Volume (TV) > 5 ml / kg, RR / TV <100 rpm/l).
- Confident awareness level (Glasgow Coma Scale (GCS)> 13).
Who cannot join
- tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation.
- For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preserving Lung Volume During Weaning and Extubation. A Prospective, Multicenter Clinical Trial
Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). There is a debate about the possible collapse of some alveolar units during such SBT and during extubation with continuous suctioning. A few experiences show extubation without suctioning as feasible and safe. Lung ultrasound is a non invasive and useful exploration tool to assess the lung aeration.
Hypothesis: Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. The preserved lung volume of each SBT and extubation strategy can be assessed by using lung ultrasound.
Read more
Primary objective: To define the rates of successful extubation in two extubation approaches aiming at different levels of lung volume preservation: standard SBT (30-min PSV 8 cmH2O without PEEP followed by extubation with continuous suctioning) versus experimental SBT (PSV8+ PEEP 5 cmH2O followed by extubation without suctioning). To define the lung aeration levels using the modified Lung Ultrasound Score (LUS) of each SBT strategy.
Secondary objectives: Reintubation rate, ICU and hospital stays, and mortality in each group. To define the diaphragm and intercostal thickness and thickening fraction in different levels of lung volume preservation.
Design: Prospective, multicenter, randomized study. Two opposing extubation strategies are compared in randomly assigned patients.The level of aeration is assessed using lung ultrasound.
Read the detailed description
HYPOTHESIS Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. Lung Ultrasound Score (LUS) might be lower in techniques aiming to preserve lung volume suggesting less lung collapse.
METHODS
Patients with inclusion criteria and none exclusion criteria will be randomized to the follow strategies:
- Standard: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning.
- Lung volume preservation: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning.
The randomization will be done with the built-in tool of the RedCap® Platform with computerized random number tables and blocks of n patients for each hospital. The investigators of each center will have a profile and a password to log into the RedCap and proceed with randomization of each patient. The investigator of each center will have access only to the data and randomization of his/her center.
In extubation failure patients (those who does not tolerate the SBT or not extubated), the attending physician will decide on the treatment, either support with non-invasive ventilation or with high flow nasal cannula, or reintubation.
Patients who present extubation failure will not be randomized in later SBTs.
During the SBT, interventions that the physician considers necessary to monitor the success of the test, such as echocardiography or thoracic ultrasound, may be performed. In the event that the physician considers that the findings of these tests do not guarantee successful extubation despite fulfillment of extubation criteria according to the study protocol, the attending physician's decision will prevail over the study protocol. In these cases, it will be recorded in the case report form (CRF) as extubation failure due to "other causes of weaning failure".
Not all patients and participating centers will collect data from the lung, diaphragm and intercostal ultrasound assessment. Only those patients that showed interest and proved ultrasound skills, will participate in the ultrasound part of the nested study.
Those patients included in the Ultrasound assessment part, an ultrasonographic exploration will be performed at different times of the SBT and extubation: before starting the SBT, at the final of the SBT and after extubation.
To proof the hypothesis related to the LUS and considering a minimum difference of 1 point (LUSm ranges from 0 to 24 points), we anticipate that 93 in each arm are required .
OBJECTIVES:
Primary: To determine the rate of successful extubation in two opposite weaning strategies.
Secondary:To determine the LUS in two opposite weaning strategies. To determine the ICU stay, hospital stay, hospital survival, and 90-day survival in the two groups. To identify the causes of extubation failure (clinical and ultrasonographic).
Exploratory:To determine the diaphragm and intercostal thickness and thickening fraction in the two groups. To describe patterns of LUS, diaphragmatic and intercostal muscles in patients who fail weaning. To assess changes in LUS during SBT and extubation specifically in posterior-basal regions. To describe diaphragmatic thickening fraction during P0.1 and Pocc maneuvers.
- Conditions
- Weaning Failure, Pulmonary Collapse
- Being tested
- Lung volume preservation
- Keywords
- Weaning from Mechanical Ventilation, Reintubation, Lung Ultrasound Score, Diaphragm and intercostal thickness and thickening fraction
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volume preservationOther
Extubate the patient connected to the ventilator and PEEP of 5 cmH2O after a successful SBT also using PEEP.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | SBT: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning. Patients included in the ultrasound nested study: * Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. * Modified LUS at the beginning of the SBT, at the end of the SBT and after extubation if successful SBT. |
| Lung Volume Preservation | Experimental | SBT: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning and connected to the ventilator with PEEP 5 cmH2O.
Patients included in the ultrasound part:
* Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT.
* Modified LUS at the beginning of the SBT, at the end of SBT and after extubation if successful SBT. Receives: Other: Lung volume preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful extubation
Number of patients free of mechanical ventilation
Measured: 72 hours
Secondary outcomes (9)
Modified Lung Ultrasound Score (LUSm) at the end of the SBT and after extubation.
Ultrasound exploration of anterior-superior, anterior-inferior, lateral and posterior-basal. From 0 (no collapse) to 36 (no areation)
Measured: 72 hours
Rate of Reintubation
Number of patients who need reintubation after successful SBT
Measured: 72 hours
Rate of ICU Mortality
Patient's Mortality during ICU stay
Measured: 90 days
Rate of Hospital Mortality
Patient's Mortality during hospital stay
Measured: 90 days
Rate of Long term survival
Number of patients alive at 90 days after randomization
Measured: 90 days
ICU length of stay
Mean of days in the ICU
Measured: 90 days
Hospital length of stay
Mean of days in the hospital
Measured: 90 days
Number of patients with tracheostomy
Patients who need tracheostomy
Measured: 90 days
Logistic regression for successful extubation
By using a multilogistic regression, the variables related to successful extubation will be identified.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start15 Jan 2023
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated to one of the two strategies: * Standard OR * Preserving Lung volume
- Masking
- None (open label)
- Enrolment
- 1,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carles Subirà Cuyàs, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Rafael Fernandez, PhD, Study director, Althaia Xarxa Assistencial de ManresaCarlos Subira, PhD, Principal investigator, Althaia Xarxa Assitencial de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526053
- Sponsor's protocol ID
- CEI 22/67
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If any researcher is interested on exploratory analysis, it should be presented to the principal investigator to get the approval for it.
Publications
Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
PubMed 7921460Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
PubMed 9927366Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
PubMed 9279224Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.
PubMed 12185425Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
PubMed 11790214Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.
PubMed 10806138Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.
PubMed 31184740Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.
PubMed 28936675Andreu M, Bertozzi M, Bezzi M, Borello S, Castro D, Giorgio VD, Aguirre M; ExtubAR group; ExtubAR group is composed by. Comparison of Two Extubation Techniques in Critically Ill Adult Subjects: The ExtubAR Randomized Clinical Trial. Respir Care. 2022 Jan;67(1):76-86. doi: 10.4187/respcare.09276. Epub 2021 Nov 3.
PubMed 34732586Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
PubMed 22584759Tenza-Lozano E, Llamas-Alvarez A, Jaimez-Navarro E, Fernandez-Sanchez J. Lung and diaphragm ultrasound as predictors of success in weaning from mechanical ventilation. Crit Ultrasound J. 2018 Jun 18;10(1):12. doi: 10.1186/s13089-018-0094-3.
PubMed 29911284Subira C, Rognoni G, Baquerizo H, Garcia C, Cabanes S, de la Torre M, Quevedo B, Pedros C, Tizon AI, Murillo N, Parro L, Eiras F, Rialp G, Altaba S, Gonzalez-Castro A, Pacheco AF, Bayoumi P, Gomez-Medrano N, Vallverdu I, Higon A, Navarro MD, Falcon A, Keough E, Arizo D, Martinez JF, Duran N, Rodriguez R, Popoviciu-Koborzan MR, Guerrero I, Concha P, Barral P, Batlle M, Cano S, Garcia-Castrillon S, Andorra X, Tua Y, Arnau A, Fernandez R. Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial. Trials. 2024 Jul 16;25(1):481. doi: 10.1186/s13063-024-08297-1.
PubMed 39014430
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserving Lung Volume During Weaning and Extubation. A Prospective, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05526053
- Acronym / sponsor ID
- CEI 22/67
- Conditions
- Weaning Failure, Pulmonary Collapse
- Keywords
- Weaning from Mechanical Ventilation, Reintubation, Lung Ultrasound Score, Diaphragm and intercostal thickness and thickening fraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,753 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 2 Sep 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.
Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). There is a debate about the possible collapse of some alveolar units during such SBT and during extubation with continuous suctioning. A few experiences show extubation without suctioning as feasible and safe. Lung ultrasound is a non invasive and useful exploration tool to assess the lung aeration.
Hypothesis: Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. The preserved lung volume of each SBT and extubation strategy can be assessed by using lung ultrasound.
Primary objective: To define the rates of successful extubation in two extubation approaches aiming at different levels of lung volume preservation: standard SBT (30-min PSV 8 cmH2O without PEEP followed by extubation with continuous suctioning) versus experimental SBT (PSV8+ PEEP 5 cmH2O followed by extubation without suctioning). To define the lung aeration levels using the modified Lung Ultrasound Score (LUS) of each SBT strategy.
Secondary objectives: Reintubation rate, ICU and hospital stays, and mortality in each group. To define the diaphragm and intercostal thickness and thickening fraction in different levels of lung volume preservation.
Design: Prospective, multicenter, randomized study. Two opposing extubation strategies are compared in randomly assigned patients.The level of aeration is assessed using lung ultrasound.
Detailed description
HYPOTHESIS Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. Lung Ultrasound Score (LUS) might be lower in techniques aiming to preserve lung volume suggesting less lung collapse.
METHODS
Patients with inclusion criteria and none exclusion criteria will be randomized to the follow strategies:
- Standard: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning.
- Lung volume preservation: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning.
The randomization will be done with the built-in tool of the RedCap® Platform with computerized random number tables and blocks of n patients for each hospital. The investigators of each center will have a profile and a password to log into the RedCap and proceed with randomization of each patient. The investigator of each center will have access only to the data and randomization of his/her center.
In extubation failure patients (those who does not tolerate the SBT or not extubated), the attending physician will decide on the treatment, either support with non-invasive ventilation or with high flow nasal cannula, or reintubation.
Patients who present extubation failure will not be randomized in later SBTs.
During the SBT, interventions that the physician considers necessary to monitor the success of the test, such as echocardiography or thoracic ultrasound, may be performed. In the event that the physician considers that the findings of these tests do not guarantee successful extubation despite fulfillment of extubation criteria according to the study protocol, the attending physician's decision will prevail over the study protocol. In these cases, it will be recorded in the case report form (CRF) as extubation failure due to "other causes of weaning failure".
Not all patients and participating centers will collect data from the lung, diaphragm and intercostal ultrasound assessment. Only those patients that showed interest and proved ultrasound skills, will participate in the ultrasound part of the nested study.
Those patients included in the Ultrasound assessment part, an ultrasonographic exploration will be performed at different times of the SBT and extubation: before starting the SBT, at the final of the SBT and after extubation.
To proof the hypothesis related to the LUS and considering a minimum difference of 1 point (LUSm ranges from 0 to 24 points), we anticipate that 93 in each arm are required .
OBJECTIVES:
Primary: To determine the rate of successful extubation in two opposite weaning strategies.
Secondary:To determine the LUS in two opposite weaning strategies. To determine the ICU stay, hospital stay, hospital survival, and 90-day survival in the two groups. To identify the causes of extubation failure (clinical and ultrasonographic).
Exploratory:To determine the diaphragm and intercostal thickness and thickening fraction in the two groups. To describe patterns of LUS, diaphragmatic and intercostal muscles in patients who fail weaning. To assess changes in LUS during SBT and extubation specifically in posterior-basal regions. To describe diaphragmatic thickening fraction during P0.1 and Pocc maneuvers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be allocated to one of the two strategies: * Standard OR * Preserving Lung volume
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –SBT: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning. Patients included in the ultrasound nested study: * Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. * Modified LUS at the beginning of the SBT, at the end of the SBT and after extubation if successful SBT. |
| Lung Volume Preservation | Experimental | Other: Lung volume preservationSBT: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning and connected to the ventilator with PEEP 5 cmH2O. Patients included in the ultrasound part: * Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. * Modified LUS at the beginning of the SBT, at the end of SBT and after extubation if successful SBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients> 18 years who meet weaning criteria (see below)
- More than 24 hours of mechanical ventilation (MV)
- Signed Informed Consent by a substitute decision maker (SDM).
- Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) < -15 cmH2O).
- Absence of excessive secretions (<3 aspirations in the last 8 hours).
Key exclusion criteria (2 listed)
- tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation.
- For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.
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 |
|---|---|---|
| Lung volume preservationExtubate the patient connected to the ventilator and PEEP of 5 cmH2O after a successful SBT also using PEEP. | Other | Lung Volume Preservation |
Primary outcome
Rate of Successful extubation
Time frame: 72 hours
Number of patients free of mechanical ventilation
9 secondary outcomes
Modified Lung Ultrasound Score (LUSm) at the end of the SBT and after extubation.
Time frame: 72 hours
Rate of Reintubation
Time frame: 72 hours
Rate of ICU Mortality
Time frame: 90 days
Rate of Hospital Mortality
Time frame: 90 days
Rate of Long term survival
Time frame: 90 days
ICU length of stay
Time frame: 90 days
Hospital length of stay
Time frame: 90 days
Number of patients with tracheostomy
Time frame: 90 days
Logistic regression for successful extubation
Time frame: 90 days
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 22 Dec 2025.
- Background: PubMed 7921460Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
- Background: PubMed 9927366Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
- Background: PubMed 9279224Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
- Background: PubMed 12185425Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.
- Background: PubMed 11790214Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
- Background: PubMed 10806138Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.
- Background: PubMed 31184740Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.
- Background: PubMed 28936675Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.
- Results publication: PubMed 34732586Andreu M, Bertozzi M, Bezzi M, Borello S, Castro D, Giorgio VD, Aguirre M; ExtubAR group; ExtubAR group is composed by. Comparison of Two Extubation Techniques in Critically Ill Adult Subjects: The ExtubAR Randomized Clinical Trial. Respir Care. 2022 Jan;67(1):76-86. doi: 10.4187/respcare.09276. Epub 2021 Nov 3.
- Results publication: PubMed 22584759Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
- Results publication: PubMed 29911284Tenza-Lozano E, Llamas-Alvarez A, Jaimez-Navarro E, Fernandez-Sanchez J. Lung and diaphragm ultrasound as predictors of success in weaning from mechanical ventilation. Crit Ultrasound J. 2018 Jun 18;10(1):12. doi: 10.1186/s13089-018-0094-3.
- Derived from this study: PubMed 39014430Subira C, Rognoni G, Baquerizo H, Garcia C, Cabanes S, de la Torre M, Quevedo B, Pedros C, Tizon AI, Murillo N, Parro L, Eiras F, Rialp G, Altaba S, Gonzalez-Castro A, Pacheco AF, Bayoumi P, Gomez-Medrano N, Vallverdu I, Higon A, Navarro MD, Falcon A, Keough E, Arizo D, Martinez JF, Duran N, Rodriguez R, Popoviciu-Koborzan MR, Guerrero I, Concha P, Barral P, Batlle M, Cano S, Garcia-Castrillon S, Andorra X, Tua Y, Arnau A, Fernandez R. Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial. Trials. 2024 Jul 16;25(1):481. doi: 10.1186/s13063-024-08297-1.
- Individual participant dataSharing planned: No. If any researcher is interested on exploratory analysis, it should be presented to the principal investigator to get the approval for it.
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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.
Rafael Fernandez, PhD study director
Althaia Xarxa Assistencial de Manresa
Carlos Subira, PhD principal investigator
Althaia Xarxa Assitencial de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung volume preservation in people with Weaning Failure and Pulmonary Collapse, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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 11 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 22 Dec 2025. 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 Spain. 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?
Rate of Successful extubation (time frame: 72 hours). 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 NCT05526053, which also lists 12 linked publications.
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 22 Dec 2025.