Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
This prospective observational cohort study aims to evaluate the prognostic value of serial bedside ultrasound assessment of diaphragmatic function in adult patients with septic shock. Diaphragmatic excursion, thickness, and thickening fraction will be assessed using point of care ultrasound at baseline and serially during the first 72 hours of intensive care admission. Dynamic changes in these parameters will be analyzed in relation to the development of respiratory failure, need for invasive mechanical ventilation, duration of mechanical ventilation, weaning and extubation outcomes, length of ICU stay, and mortality. The study will determine whether dynamic diaphragmatic ultrasound assessment can provide an early, non-invasive predictor of respiratory failure and adverse clinical outcomes in patients with septic shock.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
Patients with septic shock.
Patients with ICU admission during study period.
Expected ICU stay for at least 72 hours.
Disqualifiers
Age less than 18 years old.
Pre-existing neuromuscular disorders affecting respiratory muscles.
Known diaphragmatic paralysis or diaphragmatic palsy.
Significant phrenic nerve injury.
Trial population
The study population will consist of adult patients 18 years old or more admitted to ICU with septic shock diagnosed according to the sepsis-3 criteria. Eligible patients will be prospectively enrolled after meeting the predefined inclusion and exclusion criteria and will undergo serial bedside point of care ultrasound assessment of diaphragmatic function during the first 72 hours of ICU admission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment.
Group B: Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment.
Trial outcomes
Primary outcomes
1
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
Number of participants who develop respiratory failure requiring initiation of invasive mechanical ventilation, assessed by clinical criteria and the requirement for endotracheal intubation and invasive mechanical ventilation.
Time frame
From Baseline through Day 72
Diaphragmatic Excursion Measured by Point of Care ultrasound
Diaphragmatic Excursion measured using M mode point of care ultrasound during spontaneous breathing or ventilator supported breathing, as applicable and measured in millimeter. Three measurements will be obtained and averaged.
Time frame
Baseline, 24 hours, 48 hours, and 72 hours3
Diaphragmatic Thickness Measured by Point of Care Ultrasound
Diaphragmatic thickness measured at the zone of apposition using B mode point of care ultrasound at end expiration and measured in millimeter. Three measurements will be obtained and averaged.
Time frame
Baseline, 24 hours, 48 hours, and 72 hours4
Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound
Diaphragmatic thickening fraction measured using point of care ultrasound and calculated as \[(inspiratory thickness-expiratory thickness) / expiratory thickness\] \* 100 and measured in percentage. Three measurements will be obtained and averaged.
Time frame
Baseline, 24 hours, 48 hours, and 72 hoursSecondary outcomes
1
Time to Initiation of Invasive Mechanical Ventilation
Time from study enrollment to initiation of invasive mechanical ventilation, measured in hours
Time frame
From baseline through Day 72
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation, calculated from the initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation, measured in days.
Time frame
From initiation of invasive mechanical ventilation until successful discontinuation of invasive mechanical ventilation, assessed through ICU discharge or up to 28 days, whichever comes first.3
Number of Participants with Weaning failure
Number of participants who fail the initial attempt to discontinue invasive mechanical ventilation according to predefined clinical criteria and subsequently require continuation or resumption of mechanical ventilatory support.
Time frame
From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.4
Number of Participants With Extubation failure
Number of participants requiring reintubation and reinstitution of invasive mechanical ventilation following planned extubation.
Time frame
within 72 hours after extubation.Sponsors and contacts
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Source ClinicalTrials.gov
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