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Eine Studie entspricht den Filterkriterien
Kartenansicht
Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Adults
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07005505 ist eine interventionsstudie zur Untersuchung von Spontaneous Breathing Trial in ICU und hat den Status offene rekrutierung. Die Studie startete am 1. Juni 2025 und soll 880 Teilnehmer aufnehmen. Durchgeführt von Rush University Medical Center ist der Abschluss für 1. August 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. Juni 2025 aktualisiert.
Kurzbeschreibung
For patients requiring mechanical ventilation, spontaneous breathing trials (SBTs) are conducted to determine if it is safe to remove the breathing tube. There are multiple methods for conducting SBTs. The purpose of this study is to compare the effects of 2 methods, pressure support ventilation (PSV) versus automatic tube compensation (ATC), on successful extubation for critically ill adult patients who received mechanical ventilation for over 24 hours.
Ausführliche Beschreibung
The delivery of pressure support through the ventilator can be fixed using the pressure support ventilation (PSV) mode or variable using the automatic tube compensation (ATC) mode. Similar to PSV, ATC provides pressure support but dynamically adjusts it to compensate the resistive work of breathing and the mechanical load on respiratory muscles imposed by an artificial airway, such as an endotracheal or tracheostomy tube. Although both ATC and PSV are licensed and used in clinical practice, the optimal method to deliver pressure support during a spontaneous breathing trial (SBT) remains unknown. At Rush University Medical Center, ATC has been used for SBTs for over a decade. However, given the growing popularity of PSV, the SBT protocol was updated and now approves the use of PSV and ATC as standard care for SBT without making a recommendation for a preferred mode. The choice between PSV and ATC during SBT is left to the discretion of the clinician, reflecting the ongoing equipoise in the conduct of the SBT. As patients will be exposed to the potential benefits and risks of PSV or ATC under this change in clinical practice, the investigators are conducting a cluster-randomized cluster-crossover trial to compare the mode's effect on successful extubation.
Offizieller Titel
Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Critically Ill Adults: A Cluster-Randomized, Cluster-Crossover Trial
Erkrankungen
Spontaneous Breathing Trial in ICUPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:- Latronico N, Rasulo FA, Eikermann M, Piva S. Illness Weakness, Polyneuropathy and Myopathy: Diagnosis, treatment, and long-term outcomes. Crit Care. 2023 Nov 13;27(1):439. doi: 10.1186/s13054-023-04676-3.
- Hoshino T, Yoshida T. Spontaneous breathing-induced lung injury in mechanically ventilated patients. Curr Opin Crit Care. 2025 Feb 1;31(1):5-11. doi: 10.1097/MCC.0000000000001231. Epub 2024 Nov 8.
- Li W, Cai J, Ding L, Chen Y, Wang X, Xu H. Incidence and risk factors of ventilator-associated pneumonia in the intensive care unit: a systematic review and meta-analysis. J Thorac Dis. 2024 Sep 30;16(9):5518-5528. doi: 10.21037/jtd-24-150. Epub 2024 Sep 14.
- Guerin C, Terzi N, Mezidi M, Baboi L, Chebib N, Yonis H, Argaud L, Heunks L, Louis B. Low-pressure support vs automatic tube compensation during spontaneous breathing trial for weaning. Ann Intensive Care. 2019 Dec 13;9(1):137. doi: 10.1186/s13613-019-0611-y.
- El-Shahat, H., Salama, S., Wafy, S. et al. Automatic tube compensation versus pressure support ventilation as a weaning mode: does it make a difference?. Egypt J Bronchol 9, 253-260 (2015). https://doi.org/10.4103/1687-8426.165905
- Haberthur C, Mols G, Elsasser S, Bingisser R, Stocker R, Guttmann J. Extubation after breathing trials with automatic tube compensation, T-tube, or pressure support ventilation. Acta Anaesthesiol Scand. 2002 Sep;46(8):973-9. doi: 10.1034/j.1399-6576.2002.460808.x.
- Cohen J, Shapiro M, Grozovski E, Fox B, Lev S, Singer P. Prediction of extubation outcome: a randomised, controlled trial with automatic tube compensation vs. pressure support ventilation. Crit Care. 2009;13(1):R21. doi: 10.1186/cc7724. Epub 2009 Feb 23.
- Cardinal-Fernandez P, Bougnaud J, Cour M, Argaud L, Poole D, Guerin C. Automatic Tube Compensation During Spontaneous Breathing Trials. Respir Care. 2022 Oct;67(10):1335-1342. doi: 10.4187/respcare.09920. Epub 2022 Jun 21.
- Guttmann J, Haberthur C, Mols G, Lichtwarck-Aschoff M. Automatic tube compensation (ATC). Minerva Anestesiol. 2002 May;68(5):369-77.
- Burns KEA, Wong J, Rizvi L, Lafreniere-Roula M, Thorpe K, Devlin JW, Cook DJ, Seely A, Dodek PM, Tanios M, Piraino T, Gouskos A, Kiedrowski KC, Kay P, Mitchell S, Merner GW, Mayette M, D'Aragon F, Lamontagne F, Rochwerg B, Turgeon A, Sia YT, Charbonney E, Aslanian P, Criner GJ, Hyzy RC, Beitler JR, Kassis EB, Kutsogiannis DJ, Meade MO, Liebler J, Iyer-Kumar S, Tsang J, Cirone R, Shanholtz C, Hill NS; Canadian Critical Care Trials Group. Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial. JAMA. 2024 Dec 3;332(21):1808-1821. doi: 10.1001/jama.2024.20631.
- Burns KEA, Sadeghirad B, Ghadimi M, Khan J, Phoophiboon V, Trivedi V, Gomez Builes C, Giammarioli B, Lewis K, Chaudhuri D, Desai K, Friedrich JO. Comparative effectiveness of alternative spontaneous breathing trial techniques: a systematic review and network meta-analysis of randomized trials. Crit Care. 2024 Jun 8;28(1):194. doi: 10.1186/s13054-024-04958-4.
- Burns KEA, Khan J, Phoophiboon V, Trivedi V, Gomez-Builes JC, Giammarioli B, Lewis K, Chaudhuri D, Desai K, Friedrich JO. Spontaneous Breathing Trial Techniques for Extubating Adults and Children Who Are Critically Ill: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Feb 5;7(2):e2356794. doi: 10.1001/jamanetworkopen.2023.56794.
- Roberts KJ, Goodfellow LT, Battey-Muse CM, Hoerr CA, Carreon ML, Sorg ME, Glogowski J, Girard TD, MacIntyre NR, Hess DR. AARC Clinical Practice Guideline: Spontaneous Breathing Trials for Liberation From Adult Mechanical Ventilation. Respir Care. 2024 Jun 28;69(7):891-901. doi: 10.4187/respcare.11735.
- Mart MF, Brummel NE, Ely EW. The ABCDEF Bundle for the Respiratory Therapist. Respir Care. 2019 Dec;64(12):1561-1573. doi: 10.4187/respcare.07235. Epub 2019 Nov 5.
- Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114.
- 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.
Weitere Studien-IDs
- 25031208
NCT-Nummer
Studienbeginn (tatsächlich)
2025-06-01
Zuletzt aktualisiert
2025-06-19
Studienende (vorauss.)
2027-08
Geplante Rekrutierung
880
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Ventilator liberation
Spontaneous breathing trial
Spontaneous breathing trial
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Cross-over
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellAdult Intensive Care Unit (AICU) | Pressure Support Ventilation (PSV) Spontaneous breathing trials will be conducted using the mode pressure support ventilation (PSV) with settings of a pressure support of 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O. Automatic Tube Compensation (ATC) Spontaneous breathing trials will be conducted using the mode automatic tube compensation (ATC) with settings of 100% tube compensation and a positive end expiratory pressure (PEEP) of 5 cmH2O. |
ExperimentellMedical Intensive Care Unit (MICU) | Pressure Support Ventilation (PSV) Spontaneous breathing trials will be conducted using the mode pressure support ventilation (PSV) with settings of a pressure support of 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O. Automatic Tube Compensation (ATC) Spontaneous breathing trials will be conducted using the mode automatic tube compensation (ATC) with settings of 100% tube compensation and a positive end expiratory pressure (PEEP) of 5 cmH2O. |
ExperimentellCardiosciences Intensive Care Unit (CSICU) | Pressure Support Ventilation (PSV) Spontaneous breathing trials will be conducted using the mode pressure support ventilation (PSV) with settings of a pressure support of 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O. Automatic Tube Compensation (ATC) Spontaneous breathing trials will be conducted using the mode automatic tube compensation (ATC) with settings of 100% tube compensation and a positive end expiratory pressure (PEEP) of 5 cmH2O. |
ExperimentellNeuroscience Intensive Care Unit (NSICU) | Pressure Support Ventilation (PSV) Spontaneous breathing trials will be conducted using the mode pressure support ventilation (PSV) with settings of a pressure support of 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O. Automatic Tube Compensation (ATC) Spontaneous breathing trials will be conducted using the mode automatic tube compensation (ATC) with settings of 100% tube compensation and a positive end expiratory pressure (PEEP) of 5 cmH2O. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Reintubation | Within 48 hours of extubation | |
Death | Within 48 hours of extubation |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Time to successful extubation | The duration (in hours) from the spontaneous breathing trial (SBT) initiation to extubation without reintubation within 48 hours | From the start of the first spontaneous breathing trial (SBT) to the first successful extubation (without reintubation within 48 hours) or death from any cause, whichever occurred first, assessed up to 30 days. |
Spontaneous breathing trial (SBT) results | SBT results (pass or fail) for the first 3 attempts if conducted | Up to 30 days from study enrollment or until hospital discharge, whichever occurs first. |
Reintubation | within 24 hours of extubation | |
Reintubation | Within 72 hours of extubation | |
Reintubation | Within 7 days of extubation | |
Use of noninvasive respiratory support | Use of noninvasive ventilation, continuous positive airway pressure (CPAP), and high flow nasal cannula (HFNC) and its duration | Within 48 hours of extubation |
Total duration of mechanical ventilation | From the date of intubation to the date of extubation without reintubation within 28 hours or date of death from any cause, whichever occurs first, assessed up to 30 days. | |
Intensive care unit (ICU) length of stay (LOS) | From the date of ICU admission to the date of ICU discharge, assessed up to 30 days. | |
Hospital length of stay (LOS) | From the date of hospital admission to the date of hospital discharge, assessed up to 30 days. | |
Mortality | At intensive care unit (ICU) discharge | |
Mortality | Up to 30 days | |
Clinician adherence to initially assigned spontaneous breathing trial (SBT) mode | Up to 30 days | |
Ventilator associated complications | Including ventilator associated pneumonia, skin pressure ulcers, and barotrauma such as pneumothorax, pneumomediastinum, or subcutaneous emphysema | From the date of intubation to the date of extubation without reintubation in 48 hours or death from any cause, whichever occurs first, assessed up to 30 days. |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Admitted to intensive care unit (ICU)
- Age 18 years or older
- Requiring invasive mechanical ventilation for at least 24 hours
- Pass spontaneous breathing trial screen criteria
- Clinical decision made not to proceed with extubation regardless of spontaneous breathing trial (SBT) results
- Do not intubate (DNI) order
- Presence of tracheostomy
- Pregnancy
- Known prisoner
- Immediate need for extubation, self-extubation, or unplanned extubation that precludes safe performance of study procedures
- Enrolled in another clinical trial that impacts ventilator weaning or liberation
Verantwortliche Partei
Jie Li, Hauptprüfer, Professor, Rush University Medical Center
Zentrale Studienkontakte
Kontakt: Jie Li, PhD, 312-563-4643, [email protected]
Kontakt: Lauren Harnois, MSc, [email protected]
1 Studienstandorte in 1 Ländern
Illinois
Rush University Medical Center, Chicago, Illinois, 60612, United States
Jie Li, PhD, Kontakt, 3125634643, [email protected]
Lauren Harnois, MS, Kontakt, [email protected]
Lauren Harnois, MS, Prüfarzt
Offene Rekrutierung