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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
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Successful weaning group | 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 |
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| Weaning failure group | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Diaphragm ultrasound will be done while patient is supine on T-piece during SBT 30 minutes after disconnecting mechanical ventilation. The measurements will be done by placing the transducer in the eighth or ninth intercostal space, between the anterior axillary and the mid-axillary lines. Diaphragmatic excursion (DE) will be measured in M-mode using a 1- to 5- Megahertz (MHz) ultrasound curved transducer during maximal breathing. The amplitude of diaphragmatic excursion will be measured as the point of maximal height of the diaphragm to the base line. Diaphragmatic thickness (DT) will be measured at both end of maximal inspiration and end of maximal expiration using a high frequency 7-11 MHz ultrasound linear transducer in M-mode. The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful extubation | extubation success or failure will depend on patient needs to MV during spontaneous breathing trial (SBT), or invasive or non-invasive ventilation within 48 hours after extubation according to: respiratory rate>35/min, increased work of breathing, O2 saturation <90% with fraction of inspired oxygen (FIO2)>50%, new arrhythmias, increased heart rate>20% or more than 140b/min, drop of 20 millimetre mercury (mmHg) or rise of 30 mmHg systolic blood pressure, increased systolic blood pressure >180 mmHg in normotensive patient, change of 10 mmHg diastolic blood pressure and deterioration of blood gases value | from start of SBT till 48 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| need for tracheostomy | We will check patient need for tracheostomy since start of weaning process for 21 days and the indication for tracheostomy, if due to prolonged intubation or other causes | From start of SBT for 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Saad | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospital | Cairo | 11591 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28864053 | Background | 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. | |
| 24365607 | Background | 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. |
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Individual patient data (IPD) that underlie the results reported in this article after deidentification (texts, tables, figures and appendices) will be available only for investigators whose purposed use of the data has been approved by an independent review committee identified for this purpose
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 33309837 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |