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Fravænningsventilator ved hjælp af hjerte-, lunge- og diafragma-ultralyd

16. september 2026 opdateret af: Hanoi Medical University

Den forudsigelige værdi af hjerte-, lunge- og mellemgulvsultralyd for Ventilator-afvænningsresultater hos kirurgiske intensivpatienter

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

- 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

199

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Hanoi, Vietnam, 100000
        • Hanoi Medical University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: ECOLOGIC_OR_COMMUNITY
  • Tidsperspektiver: CROSS_SECTIONAL

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The ventilator weaning outcome
Tidsramme: after 48 hours of extubation

The outcome of weaning ventilation process (successful or failure)

after 48 hours of extubation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The hospital length of stay
Tidsramme: Approximately 5-15 days postextubation

The time between hospital admission and discharge

Approximately 5-15 days postextubation
The ICU length of stay
Tidsramme: Approximately 2-15 days postextubation

The time between ICU admission and discharge

Approximately 2-15 days postextubation
The duration of mechanical ventilation
Tidsramme: Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Tu Nguyen, Professor, Hanoi Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. april 2024

Primær færdiggørelse (Faktiske)

15. maj 2026

Studieafslutning (Faktiske)

15. august 2026

Datoer for studieregistrering

Først indsendt

27. februar 2024

Først indsendt, der opfyldte QC-kriterier

18. marts 2024

Først opslået (Faktiske)

20. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DUCGM2426

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The investigators agree that all results and conclusion of this research will be used fully for other researchers

IPD-delingstidsramme

from March 2026 to the unidentified time

IPD-delingsadgangskriterier

anesthesiologists all over the world

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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