- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07630662
Effectiveness of Diaphragmatic Function and Parasternal Intercostal Muscles Functions as Predictors for Successful Weaning From Mechanical Ventilation
Ultrasound Evaluation of Diaphragmatic Functions and Parasternal Intercostal Muscle Thickening Fraction as Predictors of Successful Weaning From Mechanical Ventilation.
Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. that is besides complications such as barotrauma, ventilator-acquired pneumonia, accumulation of secretions, and lung atelectasis.
The ultrasound estimation of parasternal intercostal muscle and diaphragmatic functions is a method to evaluate if there is a good chance of weaning outcomes.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Mechanical ventilation is a commonly used therapeutic strategy in the Intensive care unit (ICU) by providing adequate oxygenation and ventilation until improvement of the patient's condition.
Serious consequences usually follow prolonged mechanical ventilation (MV) such as barotraumas and ventilator-associated pneumonia.
On the other hand, early discontinuation of ventilation is associated with adverse cardiovascular events. Therefore, time of extubation should be anticipated properly.
Respiratory muscle dysfunction is one of the leading reasons for difficult to wean population.
There is growing evidence about the use of diaphragmatic ultrasound in evaluating both need for and weaning from mechanical ventilation. However, diaphragmatic ultrasound carry some drawbacks such as lack of echogenicity and difficult to examine left side.
Extra-diaphragmatic muscles (including parasternal intercostal muscles, scalene muscles, and sternocleidomastoid) act hand-in-hand with diaphragm to complete mechanical pump actions therefore in case of diaphragmatic dysfunction accessory respiratory muscles increase their work. This could be a possible compensatory mechanism.
Evidence support the use of parasternal intercostal muscles as a predictor of need and weaning from mechanical ventilation with perfect inter-observer reliability that could provide further details about respiratory capacity/load harmony.
We, therefore, decided to study ultrasound assessment of these muscles during weaning from MV in critically ill patients.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Mohamed I Ezz Eldein
- Telefonnummer: +2-1148394581
- E-Mail: mohamedislam@med.asu.edu.eg
Studienorte
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Cairo, Ägypten
- Rekrutierung
- Ain shams university hospitals
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Kontakt:
- Mohamed I Ezz Eldein
- Telefonnummer: +2-1148394581
- E-Mail: mohamedislam@med.asu.edu.eg
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- 1. Adult patients more than 18 years old. 2. Patient on mechanical ventilation more than 48 hours.
Exclusion Criteria:
- 1. Declining to give a written informed consent. 2. Diaphragmatic paralysis or injury
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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diaphragmatic and parasternal muscles function assessment
Patients who fulfilling the initial parameters for possibility of weaning will undergo spontaneous breathing trial (SBT) for 30 minutes. All patients will be positioned in a semi sitting position at approximately 30 degree, and will be monitored closely during SBT period. Ultrasound assessment for the parasternal intercostal and diaphragmatic muscle functions will be done at the end of SBTs for all patients. Ultrasound assessment of diaphragm: Diaphragmatic excursion; The diaphragmatic movement will be measured using a 3.5-MHz ultrasound probe. With the probe fixed on the chest wall during respiration, the patient will be asked to take a maximum breath. The right hemi-diaphragm will be measured by positioning the probe between the mid-clavicular and mid-axillary lines below the right costal margin (subcostal approach) using the liver as acoustic window. The probe will be positioned medially, cephalic and dorsally. Till the hemi-diaphragm will be well visualized. The M-mood will be ap |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Ultrasound guided muscles function assessment
Zeitfenster: 30-60 minutes
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- Evaluation of the efficacy of diaphragmatic and parasternal intercostal muscle functions as a predictors of successful weaning from mechanical ventilation.
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30-60 minutes
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
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
Andere Studien-ID-Nummern
- FMASU MD194a/2024/2026
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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