Clinical trial NCT04825509: Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome
Official title: Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome in Mechanically Ventilated Patients With Sepsis in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Failure
Sepsis
Keywords: Diaphragm ultrasound
Weaning predictor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be intubated (for 2 - 7 days) and ready for weaning process. They will undergo diaphragmatic ultrasound on spontaneous breathing pattern on T-piece connected to 8L/min O2 with subsequent outcome either successful weaning or failed weaning

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Successful extubation
timeFrame: from start of SBT till 48 hours after extubation
Secondary outcomes:
measure: need for tracheostomy
timeFrame: From start of SBT for 21 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Ain Shams University
name: Mohamed Saad
role: PRINCIPAL_INVESTIGATOR
References:
citation: Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.
citation: DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
citation: Kilaru D, Panebianco N, Baston C. Diaphragm Ultrasound in Weaning From Mechanical Ventilation. Chest. 2021 Mar;159(3):1166-1172. doi: 10.1016/j.chest.2020.12.003. Epub 2020 Dec 10.