Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome

Ain Shams University

Status: Completed

Conditions: Weaning Failure; Sepsis

Treatments: Device: Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04825509

Diaphragm Ultrasound

Details and patient eligibility

About

This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening measured by ultrasound during a weaning trial may be used to predict successful weaning from mechanical ventilation in patients with sepsis in intensive care unit

Full description

After being informed about the study and giving written informed consent, Intubated and mechanically ventilated patients with sepsis on admission and fulfilling criteria of weaning from mechanical ventilation (MV), will undergo diaphragm ultrasound during spontaneous breathing trial on T-piece. We will measure diaphragm excursion (DE), diaphragm thickness (DT) and calculate diaphragm thickness fraction (DTF):

DT during inspiration - DT during expiration / DT during expiration

According to weaning outcome, patients will be divided into 2 groups:

• Successful weaning group
• Weaning failure group

By statistical analysis we will define the cut off value and area under curve (AUC) for DE and DTF and we can confirm if DE and DTF using ultrasound can be used as predictors for weaning from MV or not

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes, aging 18 - 60 years after written informed consent
• Patients with sepsis on admission according to the new sepsis definition in 2016 (life-threatening organ dysfunction due to a dysregulated host response to infection)
• Hemodynamically stable without or with low dose support
• Patients on mechanical ventilation for at least 48 hours and not more than 1 week
• Patients ready for start of weaning protocol, fully conscious, on continuous positive airway pressure (CPAP) mode with positive end expiratory pressure (PEEP) 3-5 Centimetre water (CmH2O), Pr. Supp. <15 CmH2O, Fio2 less than 60%, Respiratory rate less than 35 breath/min, partial oxygen pressure (PO2)/FIO2 >200, Rapid Shallow Breathing Index (RSBI) is less than 105

Exclusion criteria

• Patients aged less than 18 years or more than 60 years old
• Patients in septic shock, hemodynamically unstable or on high dose support
• Patients on mechanical ventilation for more than 1 week or less than 48 hours
• Patients not ready for start of weaning from mechanical ventilation
• Patients with neuromuscular disorders
• Pregnant females in the second and third trimester, patients with tense ascites or morbidly obese with body mass index more than 40 kg/m2

Trial design

60 participants in 2 patient groups

Successful weaning group

Description:

Patients will be in this group according to primary outcome, if they will succeed spontaneous breathing trial for 120 minutes and will be extubated successfully without need for invasive or non-invasive ventilation for 48 hours

Treatment:

Device: Ultrasound

Weaning failure group

Description:

Patients will be in this group according to primary outcome, if they will fail spontaneous breathing trial or extubation within 48 hours Weaning failure will be considered if: * Patients will need MV during spontaneous breathing trial within 120 minutes, or * patients will need invasive or non-invasive ventilation within 48 hours

Treatment:

Device: Ultrasound