Beta
Trial Radar KI
enums.trial_summary.trial_summary_welcome
Eine Studie entspricht den Filterkriterien
Kartenansicht

Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Adults

Offene Rekrutierung
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 ICU
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
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
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Cross-over
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/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
ErgebnismessungBeschreibung der MessungZeitrahmen
Reintubation
Within 48 hours of extubation
Death
Within 48 hours of extubation
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Rush University Medical Center logoRush University Medical Center
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