Entwöhnungsbeatmungsgerät mittels Herz-, Lungen- und Zwerchfellultraschall
Der prädiktive Wert von Herz-, Lungen- und Zwerchfellultraschall für das Ergebnis der Beatmungsentwöhnung bei chirurgischen Intensivpatienten
Postextubation distress is detrimental to the prognosis of critically ill patients with successful spontaneous breathing trial. Failure to wean is known to be connected with heart, lung, and diaphragm problems. The aim of this study was to investigate how a composite model comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning outcome.
Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected along with clinical data about the patients. Either the successful weaning group or the failed weaning group is going to comprised the patients. Multivariate logistic regression analysis is going to be used to identify the variables that may be associated with the likelihood of weaning failure. A multiindicator combination model is going to be developed to increase the predictive accuracy after the possible indicators' accuracy in foretelling the weaning outcome was assessed.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
- Research participants: From March 2024 to March 2026 in the Department of Anesthesia, critical care and pain medicine, Hanoi Medical University Hospital, patients ages over 18 years who will have mechanically ventilated for over 48 h will be recruited. Patients will be excluded if they had a diagnosis of progressive neuromuscular diseases, a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma), patients with thoracic surgery and mitral valve surgery. All patients and their families signed informed consents.
- Clinical data collection: Clinical data including gender, age, body mass index, primary disease, length of stay in ICU, duration of mechanical ventilation, acute physiology and chronic health evaluation II, Charlson Comorbidity Index, history of surgery/internal diseases will be collected.
- Spontaneous breathing trial (SBT): Patients will be undergone a 60-min SBT when they meet all the readiness weaning criteria with PS 7cmH2O, PEEP 5cmH2O, FiO2 40%. The vital signs, rapid shallow breathing index (RSBI), NIF, P0.1, tidal volume, respiratory rate, arterial blood gases will be recorded at the beginning and at the end of SBT.
GE Logiq P7 (GE Healthcare, USA) and Philips Affiniti 70G (Philips Ultrasound, USA) ultrasound diagnostic instruments will be used in this study. The heart, lung and diagphragm ultrasonic findings will be recorded by the sonographer well trained in point-of-care ultrasound at the begining and at the end of the SBT.
Tracheal extubation is carried out if the patient does not exhibit symptoms of intolerance, indicating that the SBT treatment was successful. In case intolerance symptoms manifest, return to the initially chosen breathing mode (SIMV, A/C) and record the SBT failure.
- Extubation: After successful SBT: proceed with extubation. The patient is given an oxygen mask at 5L/minute. If the patient does not show intolerance symptoms within 48 hours, the extubation is considered successful. If the patient develops one of the intolerance symptoms during this time period, the extubation failure will be recorded and the patients will be reintubated. Record the values of vital signs and arterial blood gas variables every 24, 48 hours after extubation.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Hanoi, Vietnam, 100000
- Hanoi Medical University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
All patients with a duration of mechanical ventilation through an endotracheal tube of more than 48 hours and meeting the criteria of readiness to wean off mechanical ventilation will be included in the study.
Beschreibung
Inclusion Criteria:
- Age >= 18
- The duration of postoperative mechanical ventilation >= 48 hours
Exclusion Criteria:
- Patient had a diagnosis of progressive neuromuscular diseases
- Patient had a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma)
- Patients had thoracic surgery or mitral valve surgery.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: ECOLOGIC_OR_COMMUNITY
- Zeitperspektiven: CROSS_SECTIONAL
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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The ventilator weaning patients
Patients who have been on mechanical breathing for longer than 48 hours using an endotracheal tube and who fit the requirements to be weaned off of it |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The ventilator weaning outcome
Zeitfenster: after 48 hours of extubation
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The outcome of weaning ventilation process (successful or failure) |
after 48 hours of extubation
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The hospital length of stay
Zeitfenster: Approximately 5-15 days postextubation
|
The time between hospital admission and discharge |
Approximately 5-15 days postextubation
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The ICU length of stay
Zeitfenster: Approximately 2-15 days postextubation
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The time between ICU admission and discharge |
Approximately 2-15 days postextubation
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The duration of mechanical ventilation
Zeitfenster: Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months
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The time from the start of mechanical ventilation to extubation |
Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Tu Nguyen, Professor, Hanoi Medical University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- DUCGM2426
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
The investigators agree that all results and conclusion of this research will be used fully for other researchers
IPD-Sharing-Zeitrahmen
from March 2026 to the unidentified time
IPD-Sharing-Zugriffskriterien
anesthesiologists all over the world
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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