- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07702422
The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation
The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation: A Prospective Cohort Study.
Approximately 20% of patients in the intensive care unit (ICU) requiring mechanical ventilation (MV) experience difficulty and prolonged weaning. Early spontaneous breathing trials (SBT) and timely extubation are essential to avoid complications such as diaphragmatic dysfunction, ventilator-associated pneumonia, and airway trauma.
Mechanical ventilation is a vital supportive therapy in critical care. However, both delayed weaning and premature discontinuation are associated with poor outcomes and prolonged ICU stay. Prolonged MV may lead to complications including respiratory muscle dysfunction, ventilator-associated lung injury, and increased healthcare costs, emphasizing the importance of optimal timing of weaning.
Ultrasonography (US) has emerged as a rapid, non-invasive bedside tool for real-time assessment of respiratory muscle function. It allows evaluation of muscle thickness and contractility, aiding in the detection of diaphragmatic dysfunction.
In cases of diaphragmatic impairment, accessory respiratory muscles, particularly the parasternal intercostal muscles, play a compensatory role. Measurement of parasternal intercostal muscle thickness fraction (PICTF%) has been proposed as a predictor of weaning failure.
Additionally, composite indices such as the rapid shallow breathing index (RSBI) and compliance, rate, oxygenation, and pressure (CROP) index are widely used to assess weaning readiness. A recently proposed composite index combining PICTF (>9%) and diaphragmatic excursion (<15 mm) demonstrated high predictive value for failure of non-invasive ventilation.
Therefore, the present study aims to evaluate the effectiveness of this novel composite index in predicting weaning failure in mechanically ventilated patients.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
- All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
- Neuromuscular diseases.
- Severe head injury.
- Pregnant and lactating women.
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years old.
- Both sexes.
- Patients who have been mechanically ventilated for more than 48 h.
Exclusion Criteria:
- All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
- Neuromuscular diseases.
- Severe head injury.
- Pregnant and lactating women.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ability of a combined PICTF% and diaphragmatic excursion to predict weaning failure .
Tidsramme: 5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail
|
Parasternal intercostal muscle thickening fraction (%) measured by ultrasound at 5 minutes after the start of the spontaneous breathing trial to evaluate its ability to predict weaning failure and diaphragmatic excursion
|
5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
• Difference between PICTF % at 5 and 60 min OF SBT. • RSBI at 5and 60 min of SBT. • Correlation between PICTF% and RSBI Diaphragmatic excursion
Tidsramme: at 5 mintues of spontanous breathing trail and at 60 minutes
|
at 5 mintues of spontanous breathing trail and at 60 minutes
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- md-461-2024
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