Critical IllnessEXTUBATENCT06391424
Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)
An observational study of Critical Illness and Intensive Care Unit, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care Unit, Oxygen Consumption
- What is being tested?
- Spontaneous Breathing Trial
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2024to Jan 2026
- How long will I take part?
- 2 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended population consists of adults who are mechanically ventilated in the ICU and meet the criteria for a regular spontaneous breathing trial according to the ruling LUMC protocol.
Who may be able to join
- Age above 18 years
- > 24 hours mechanically ventilated
- Eligible for a spontaneous breathing trial according to the clinical team
- Regular SBT ("Regulier SBT") according to the Leiden University Medical Center (LUMC) protocol
- Hemodynamically stable
- Esophageal Catheter in situ
Who cannot join
- Severe chronic obstructive pulmonary disease (COPD) (Gold class IV) if it results in a non regular SBT according to the LUMC protocol.
- Heart failure (LVEF <30%) if it results in a non regular SBT according to the LUMC protocol
- Known pregnancy
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland, 2333 ZA
Abraham Schoe, MD, PhD, +31-715265018, a.schoe@lumc.nl
Abraham Schoe, MD, PhD
- Not yet recruiting
Leiden University Medical Center
Leiden, 2333ZA
Abraham Schoe, MD PhD, a.schoe@lumc.nl
Florence E Smits, MSc, f.e.smits@lumc.nl
About this study
Official title: Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): EXTUBATE Study
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.
Read the detailed description
Weaning failure is a common problem in patients who are mechanically ventilated for more than 72 hours. Prediction of successful extubation is crucial for mechanically ventilated (MV) intensive care patients. Prolonged intubation leads to prolonged mechanical ventilation, which is known to have undesirable and detrimental effects. Premature extubation, on the other hand, is associated with clinical deterioration, a second episode of mechanical ventilation, and prolonged mechanical ventilation, resulting in multiple adverse outcomes.
In addition, up to 20% of all Intensive Care Unit (ICU) patients fail to wean from mechanical ventilation. Prolonged mechanical ventilation is associated with half of the total time spent on the ICU. Improving the prediction of successful weaning provides physicians with a mean to optimize extubation timing, while reducing the incidence of premature extubation.
The rapid shallow breathing index (RSBI) is a parameter commonly used to predict extubation success, next to some other clinical parameters such as consciousness level, the ability to cough and muscle strength. The most commonly used RSBI cut-off value for predicting save extubation incorrectly classifies 15% to 20% of patients. Which means that those patients require another period of mechanical ventilation with possible adverse consequences. It is therefore necessary to develop new parameters or indices aiding in the guidance of extubation timing.
Various other parameters, such as work of breathing (WOB), transpulmonary pressure swings (PS) and the pressure time product (PTP), which are manifestations of patient effort, have been investigated. Although a difference in transpulmonary pressure swings during a spontaneous breathing trial (SBT) has been linked to weaning failure, it has yet to be determined whether transpulmonary pressure swings predict extubation success or failure. For all these measures of effort the placement of an esophageal catheter is obligatory.
Oxygen consumption (VO2) is a direct manifestation of patient effort. It is defined as the difference between the amount of oxygen inhaled and exhaled over a predetermined time interval. Using end tidal oxygen (etO2) measurements and volumetric calculations, it is feasible to track VO2 variations breath-by-breath. A change in oxygen consumption during an SBT could be an early indicator of patient effort and failure.
The investigators hypothesize that VO2 measurement, together with indices of patient effort, could be valuable additional parameters when estimating weaning failure or success, and therefore, aid in the prediction of extubation success or failure.
- Conditions
- Critical Illness, Intensive Care Unit, Oxygen Consumption, Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial
- Being tested
- Spontaneous Breathing Trial
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous Breathing TrialDiagnostic test
Patients will undergo an SBT to determine whether they are ready for extubation.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous Breathing Trial | Patients who will undergo a spontaneous breathing trial Receives: Diagnostic Test: Spontaneous Breathing Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of weaning failure
weaning failure is defined as not meeting the criteria for a succesful spontaneous breathing trial (SBT) or extubation failure, defined as the need for re-intubation within 48 hours, after a succesful SBT and subsequent extubation.
Measured: 48 hours after SBT
Differences of oxygen consumption during SBT
The values of oxygen consumption (in milliliter/minute) and the differences between start, during, and end of the SBT.
Measured: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Secondary outcomes (4)
Differences of esophageal pressure swings measured with an esophageal catheter during SBT
The values of pressure swings (in cmH2O), measured with an esophageal catheter, and the differences between start, during, and end of the SBT.
Measured: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of work of breathing measured with an esophageal catheter during SBT
The values of work of breathing (in Joules/liter), measured with an esophageal catheter, and the differences between start, during, and end of the SBT.
Measured: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of pressure time product measured with an esophageal catheter during SBT
The values of pressure time product (in cmH2O/seconds), measured with an esophageal catheter, and the differences between start, during, and end of the SBT.
Measured: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of rapid shallow breathing index during SBT
The values of rapid shallow breathing index (breaths/minute/liter) and the differences between start, during, and end of the SBT.
Measured: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jan 2024
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abraham Schoe, MD, PhD., Leiden University Medical Center
- Investigators
- Abraham Schoe, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391424
- Sponsor's protocol ID
- P23.068
- Acronym
- EXTUBATE
- Status last verified
- Sep 2024
- First submitted
- 15 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon request with researchers.
Publications
Trudzinski FC, Neetz B, Bornitz F, Muller M, Weis A, Kronsteiner D, Herth FJF, Sturm N, Gassmann V, Frerk T, Neurohr C, Ghiani A, Joves B, Schneider A, Szecsenyi J, von Schumann S, Meis J. Risk Factors for Prolonged Mechanical Ventilation and Weaning Failure: A Systematic Review. Respiration. 2022;101(10):959-969. doi: 10.1159/000525604. Epub 2022 Aug 17.
PubMed 35977525Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PubMed 27626706Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.
PubMed 9228375Li F, Nie J, Lu Y, Tong TK, Yi L, Yan H, Fu FH, Ma S. The impact of intermittent exercise in a hypoxic environment on redox status and cardiac troponin release in the serum of well-trained marathon runners. Eur J Appl Physiol. 2016 Oct;116(10):2045-51. doi: 10.1007/s00421-016-3460-5. Epub 2016 Aug 29.
PubMed 27572505Pham T, Telias I, Beitler JR. Esophageal Manometry. Respir Care. 2020 Jun;65(6):772-792. doi: 10.4187/respcare.07425.
PubMed 32457170Jubran A, Grant BJ, Laghi F, Parthasarathy S, Tobin MJ. Weaning prediction: esophageal pressure monitoring complements readiness testing. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1252-9. doi: 10.1164/rccm.200503-356OC. Epub 2005 Mar 11.
PubMed 15764727McClave SA, Kleber MJ, Lowen CC. Indirect calorimetry: can this technology impact patient outcome? Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):61-7. doi: 10.1097/00075197-199901000-00011.
PubMed 10453332Takala J, Keinanen O, Vaisanen P, Kari A. Measurement of gas exchange in intensive care: laboratory and clinical validation of a new device. Crit Care Med. 1989 Oct;17(10):1041-7. doi: 10.1097/00003246-198910000-00015.
PubMed 2676345Bellani G, Foti G, Spagnolli E, Milan M, Zanella A, Greco M, Patroniti N, Pesenti A. Increase of oxygen consumption during a progressive decrease of ventilatory support is lower in patients failing the trial in comparison with those who succeed. Anesthesiology. 2010 Aug;113(2):378-85. doi: 10.1097/ALN.0b013e3181e81050.
PubMed 20613464Smits FE, Rietveld PJ, Snoep JWM, van der Velde-Quist F, de Jonge E, Schoe A. P0.1 is an Unreliable Measure of Effort in Support Mechanical Ventilation in Comparison With Esophageal-Derived Measures of Effort: A Comparison Study. Crit Care Med. 2025 Aug 1;53(8):e1650-e1658. doi: 10.1097/CCM.0000000000006745. Epub 2025 Jun 11.
PubMed 40638487Smits FE, Rietveld PJ, Snoep JWM, van der Velde-Quist F, de Jonge E, Schoe A. Oxygen consumption, effort, and weaning in the mechanically ventilated patient in the intensive care unit: The extubate study: A protocol for an observational study. Respir Med. 2025 Feb;237:107949. doi: 10.1016/j.rmed.2025.107949. Epub 2025 Jan 16.
PubMed 39826764
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): EXTUBATE Study
- ClinicalTrials.gov ID
- NCT06391424
- Acronym / sponsor ID
- EXTUBATE / P23.068
- Conditions
- Critical Illness, Intensive Care Unit, Oxygen Consumption, Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 30 Apr 2024 (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.
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.
Detailed description
Weaning failure is a common problem in patients who are mechanically ventilated for more than 72 hours. Prediction of successful extubation is crucial for mechanically ventilated (MV) intensive care patients. Prolonged intubation leads to prolonged mechanical ventilation, which is known to have undesirable and detrimental effects. Premature extubation, on the other hand, is associated with clinical deterioration, a second episode of mechanical ventilation, and prolonged mechanical ventilation, resulting in multiple adverse outcomes.
In addition, up to 20% of all Intensive Care Unit (ICU) patients fail to wean from mechanical ventilation. Prolonged mechanical ventilation is associated with half of the total time spent on the ICU. Improving the prediction of successful weaning provides physicians with a mean to optimize extubation timing, while reducing the incidence of premature extubation.
The rapid shallow breathing index (RSBI) is a parameter commonly used to predict extubation success, next to some other clinical parameters such as consciousness level, the ability to cough and muscle strength. The most commonly used RSBI cut-off value for predicting save extubation incorrectly classifies 15% to 20% of patients. Which means that those patients require another period of mechanical ventilation with possible adverse consequences. It is therefore necessary to develop new parameters or indices aiding in the guidance of extubation timing.
Various other parameters, such as work of breathing (WOB), transpulmonary pressure swings (PS) and the pressure time product (PTP), which are manifestations of patient effort, have been investigated. Although a difference in transpulmonary pressure swings during a spontaneous breathing trial (SBT) has been linked to weaning failure, it has yet to be determined whether transpulmonary pressure swings predict extubation success or failure. For all these measures of effort the placement of an esophageal catheter is obligatory.
Oxygen consumption (VO2) is a direct manifestation of patient effort. It is defined as the difference between the amount of oxygen inhaled and exhaled over a predetermined time interval. Using end tidal oxygen (etO2) measurements and volumetric calculations, it is feasible to track VO2 variations breath-by-breath. A change in oxygen consumption during an SBT could be an early indicator of patient effort and failure.
The investigators hypothesize that VO2 measurement, together with indices of patient effort, could be valuable additional parameters when estimating weaning failure or success, and therefore, aid in the prediction of extubation success or failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous Breathing Trial | – | Diagnostic Test: Spontaneous Breathing TrialPatients who will undergo a spontaneous breathing trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended population consists of adults who are mechanically ventilated in the ICU and meet the criteria for a regular spontaneous breathing trial according to the ruling LUMC protocol.
Key inclusion criteria (6 listed)
- Age above 18 years
- > 24 hours mechanically ventilated
- Eligible for a spontaneous breathing trial according to the clinical team
- Regular SBT ("Regulier SBT") according to the Leiden University Medical Center (LUMC) protocol
- Hemodynamically stable
Key exclusion criteria (3 listed)
- Severe chronic obstructive pulmonary disease (COPD) (Gold class IV) if it results in a non regular SBT according to the LUMC protocol.
- Heart failure (LVEF <30%) if it results in a non regular SBT according to the LUMC protocol
- Known pregnancy
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 |
|---|---|---|
| Spontaneous Breathing TrialPatients will undergo an SBT to determine whether they are ready for extubation. | Diagnostic test | Spontaneous Breathing Trial |
Primary outcome
Incidence of weaning failure
Time frame: 48 hours after SBT
weaning failure is defined as not meeting the criteria for a succesful spontaneous breathing trial (SBT) or extubation failure, defined as the need for re-intubation within 48 hours, after a succesful SBT and subsequent extubation.
Differences of oxygen consumption during SBT
Time frame: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
The values of oxygen consumption (in milliliter/minute) and the differences between start, during, and end of the SBT.
4 secondary outcomes
Differences of esophageal pressure swings measured with an esophageal catheter during SBT
Time frame: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of work of breathing measured with an esophageal catheter during SBT
Time frame: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of pressure time product measured with an esophageal catheter during SBT
Time frame: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of rapid shallow breathing index during SBT
Time frame: 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 35977525Trudzinski FC, Neetz B, Bornitz F, Muller M, Weis A, Kronsteiner D, Herth FJF, Sturm N, Gassmann V, Frerk T, Neurohr C, Ghiani A, Joves B, Schneider A, Szecsenyi J, von Schumann S, Meis J. Risk Factors for Prolonged Mechanical Ventilation and Weaning Failure: A Systematic Review. Respiration. 2022;101(10):959-969. doi: 10.1159/000525604. Epub 2022 Aug 17.
- Background: PubMed 27626706Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
- Background: PubMed 9228375Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.
- Background: PubMed 27572505Li F, Nie J, Lu Y, Tong TK, Yi L, Yan H, Fu FH, Ma S. The impact of intermittent exercise in a hypoxic environment on redox status and cardiac troponin release in the serum of well-trained marathon runners. Eur J Appl Physiol. 2016 Oct;116(10):2045-51. doi: 10.1007/s00421-016-3460-5. Epub 2016 Aug 29.
- Background: PubMed 32457170Pham T, Telias I, Beitler JR. Esophageal Manometry. Respir Care. 2020 Jun;65(6):772-792. doi: 10.4187/respcare.07425.
- Background: PubMed 15764727Jubran A, Grant BJ, Laghi F, Parthasarathy S, Tobin MJ. Weaning prediction: esophageal pressure monitoring complements readiness testing. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1252-9. doi: 10.1164/rccm.200503-356OC. Epub 2005 Mar 11.
- Background: PubMed 10453332McClave SA, Kleber MJ, Lowen CC. Indirect calorimetry: can this technology impact patient outcome? Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):61-7. doi: 10.1097/00075197-199901000-00011.
- Background: PubMed 2676345Takala J, Keinanen O, Vaisanen P, Kari A. Measurement of gas exchange in intensive care: laboratory and clinical validation of a new device. Crit Care Med. 1989 Oct;17(10):1041-7. doi: 10.1097/00003246-198910000-00015.
- Background: PubMed 20613464Bellani G, Foti G, Spagnolli E, Milan M, Zanella A, Greco M, Patroniti N, Pesenti A. Increase of oxygen consumption during a progressive decrease of ventilatory support is lower in patients failing the trial in comparison with those who succeed. Anesthesiology. 2010 Aug;113(2):378-85. doi: 10.1097/ALN.0b013e3181e81050.
- Derived from this study: PubMed 40638487Smits FE, Rietveld PJ, Snoep JWM, van der Velde-Quist F, de Jonge E, Schoe A. P0.1 is an Unreliable Measure of Effort in Support Mechanical Ventilation in Comparison With Esophageal-Derived Measures of Effort: A Comparison Study. Crit Care Med. 2025 Aug 1;53(8):e1650-e1658. doi: 10.1097/CCM.0000000000006745. Epub 2025 Jun 11.
- Derived from this study: PubMed 39826764Smits FE, Rietveld PJ, Snoep JWM, van der Velde-Quist F, de Jonge E, Schoe A. Oxygen consumption, effort, and weaning in the mechanically ventilated patient in the intensive care unit: The extubate study: A protocol for an observational study. Respir Med. 2025 Feb;237:107949. doi: 10.1016/j.rmed.2025.107949. Epub 2025 Jan 16.
- Individual participant dataSharing planned: Undecided. Data will be shared upon request with researchers.
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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.
Abraham Schoe, MD PhD principal investigator
Leiden University Medical Center
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 Critical Illness and Intensive Care Unit, run by Leiden University Medical Center at 2 sites in Netherlands.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence E Smits, MSc (+31 (0)71-5262164, f.e.smits@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of weaning failure (time frame: 48 hours after SBT). The study lists 2 primary outcomes in all. 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 NCT06391424, which also lists 11 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 19 Sep 2024.