- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03094299
Diaphragm Ultrasound in Weaning From Mechanical Ventilation
The Efficacy of Ultrasound Assessment of Diaphragmatic Function in Guiding Weaning From Mechanical Ventilation in Critically Ill Patients With Abdominal Sepsis
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume); however, sensitivity and specificity for most variables are still variable in literature.
Diaphragmatic dysfunction is a common cause of weaning failure (2) however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening. In this study we will evaluate the ability of the diaphragmatic function to predict weaning success in patients with abdominal sepsis.
After weaning, patients will be divided into two groups; group of successful weaning (group S) and group with failed weaning (group F) both groups will be compared as regards all clinical, laboratory, and ultrasonographic parameters recorded before weaning, further analysis will be done for patients with repeated trials of weaning (more than one trial or more than one week MV) and those with simple weaning (first time for weaning).
A 7-10 Mega Hertz linear ultrasound probe (Mindray machine) set to B mode, the diaphragm will be visualized by placing the transducer perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and the midaxillary lines, to observe the zone of apposition of the muscle 0.5 to 2 cm below the costophrenic sinus.
The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then, the diaphragmatic fraction thickening (DTF) will be calculated as percentage Diaphragmatic movement will be measured in all patients with a 3.5 Mega Hertz US probe placed over one of the lower intercostal spaces in the right anterior axillary line for the right diaphragm and the left midaxillary line for the left diaphragm.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Cairo, Egypten
- Cairo University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Critically ill patients with abdominal sepsis with history of MV for more than 48 hours
Exclusion Criteria:
- Age < 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. Also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diaphragmatic thickening fraction
Tidsramme: five minutes before spontaneous breathing trial
|
(calculated as maximum thickness - minimum thickness / maximum thickness)
|
five minutes before spontaneous breathing trial
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diaphragmatic excursion
Tidsramme: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
(measured in millimeters)
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Rapid shallow breathing index (RSBI)
Tidsramme: five minutes before spontaneous breathing trial
|
Respiratory rate/tidal volume in litres
|
five minutes before spontaneous breathing trial
|
Arterial blood gases
Tidsramme: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Partial oxygen pressure and Partial carbon dioxide pressure
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Number of weaning trials
Tidsramme: during the last 7 days
|
number of weaning trials before this trial
|
during the last 7 days
|
Heart rate
Tidsramme: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
the patient heart rate measured as beat.minute
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Arterial blood pressure
Tidsramme: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
systolic and diastolic blood pressure measured in mmHg
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N-16-2017
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Abdominal sepsis
-
University of CalgaryAlberta Health servicesRekrutteringAbdominal sepsis | Abdominal infektionCanada
-
Nanjing PLA General HospitalAfsluttetIntra-abdominal perforering
-
Universidad Autonoma de San Luis PotosíUkendt
-
Jinling Hospital, ChinaAfsluttetFistel i fordøjelsessystemet | Blindtarmsbetændelse | Abdominal byld | Pancreatitis | Alvorlig sepsisKina
-
Aristotle University Of ThessalonikiAfsluttet
-
Tianjin Medical University Cancer Institute and...Zhejiang Hisun Pharmaceutical Co. Ltd.UkendtAbdominal infektionKina
-
Milton S. Hershey Medical CenterTrukket tilbageSepsis | Septisk chok | Dysfunktion af flere organer | Intraabdominal sepsis
-
University Hospital OstravaAfsluttetSepsis | Traumeskade | Større abdominal kirurgiTjekkiet
-
Assiut UniversityIkke rekrutterer endnuKritisk syg | Abdominal sepsisEgypten
-
Aisthesis Medical P.C.Larissa University Hospital; Technical University of CreteRekrutteringInfektioner | Sepsis | Hæmodynamisk ustabilitet | Abdominal sepsis | Klinisk forringelseGrækenland