An observational study in Respiration Failure, Diaphragmatic Dysfunction and Mechanical Ventilation, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Assiut University · Observational
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.
Septic shock remains a major cause of morbidity and mortality among critically ill patients. Respiratory failure is a frequent and serious complication, resulting from a combination of sepsis-induced lung injury, acute respiratory distress syndrome, respiratory muscle dysfunction, and sepsis-induced myopathy. The diaphragm is the principal muscle of respiration and may be significantly affected during sepsis. Systemic inflammation, altered microcirculation, mitochondrial dysfunction, electrolyte abnormalities, prolonged immobilization, sedation, and mechanical ventilation can contribute to diaphragmatic dysfunction. Such dysfunction may impair spontaneous breathing, increase the risk of respiratory failure, prolong mechanical ventilation, and contribute to unsuccessful weaning and adverse clinical outcomes. Point-of-care ultrasound (POCUS) provides a non-invasive, bedside, radiation-free method for assessing diaphragmatic structure and function. The most commonly used parameters include diaphragmatic excursion (DE), diaphragmatic thickness, and diaphragmatic thickening fraction (DTF). Most available studies have assessed diaphragmatic function at a single point in time, particularly during weaning from mechanical ventilation. However, limited evidence exists regarding the prognostic value of serial dynamic assessment of diaphragmatic function in patients with septic shock from the early stages of ICU admission.
Dynamic changes in diaphragmatic function may provide more clinically meaningful information than a single measurement. Therefore, serial POCUS assessment may help identify patients at high risk of respiratory failure and predict important clinical outcomes.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment. primary respiratory outcome: Development of respiratory failure requiring invasive mechanical ventilation within 7 days after enrollment.
Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment. outcomes: Duration of mechanical ventilation, weaning failure, extubation failure or reintubation, ICU and hospital mortality and ICU length of stay.
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 7
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 hours
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 hours
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 hours
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 7
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.
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.
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.
Duration of Intensive Care Unit stay
Duration of stay in the intensive care unit from ICU admission until ICU discharge, measured in days.
Time frame: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
Number of Participants Who Die During Intensive Care Unit Stay
Number of participants who die during the Intensive Care Unit stay
Time frame: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Mar 2028, 17 months later.
Of 232 non-industry observational studies under Respiratory Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 17 months is below that.
Counting every sponsor, half of 248 studies reached it within 22 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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