Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome

Completed

• Conditions: Weaning Failure; Sepsis
• Interventions: Device: Ultrasound

• Registration Number: NCT04825509
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-04-18
• Primary Completion: 2021-10-17
• Study Completion: 2021-11-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weaning failure group	Ultrasound	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
Successful weaning group	Ultrasound	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

Primary Outcome Measures

Name	Time	Method
Successful extubation	from start of SBT till 48 hours after 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

Secondary Outcome Measures

Name	Time	Method
need for tracheostomy	From start of SBT for 21 days	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

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt