- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06321848
Ventilatore per lo svezzamento mediante ultrasuoni del cuore, dei polmoni e del diaframma
Il valore predittivo degli ultrasuoni del cuore, del polmone e del diaframma per l'esito dello svezzamento dal ventilatore dei pazienti in terapia intensiva chirurgica
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
- 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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Hanoi, Vietnam, 100000
- Hanoi Medical University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: ECOLOGIC_OR_COMMUNITY
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
|---|
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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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The ventilator weaning outcome
Lasso di tempo: after 48 hours of extubation
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The outcome of weaning ventilation process (successful or failure) |
after 48 hours of extubation
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The hospital length of stay
Lasso di tempo: 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
Lasso di tempo: Approximately 2-15 days postextubation
|
The time between ICU admission and discharge |
Approximately 2-15 days postextubation
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The duration of mechanical ventilation
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Tu Nguyen, Professor, Hanoi Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- DUCGM2426
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
The investigators agree that all results and conclusion of this research will be used fully for other researchers
Periodo di condivisione IPD
from March 2026 to the unidentified time
Criteri di accesso alla condivisione IPD
anesthesiologists all over the world
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .