Diaphragmatic Dysfunction, Mechanical Ventilation, Respiration Failure, Septic Shock
Conditions
Keywords
POCUS, septic shock, respiratory failure, diaphragm
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old. * Patients with septic shock. * Patients with ICU admission during study period. * Expected ICU stay for at least 72 hours. * Informed consent from the patient or legal guardian when required.
Exclusion criteria
* Age less than 18 years old. * Pre-existing neuromuscular disorders affecting respiratory muscles. * Known diaphragmatic paralysis or diaphragmatic palsy. * Significant phrenic nerve injury. * Cervical spinal cord injury. * Advanced chronic neuromuscular disease. * Previous major thoracic or diaphragmatic surgery. * Severe chest wall deformity. * Conditions preventing adequate diaphragmatic ultrasound assessment. * Pregnancy, if required by local ethical policy. * Patients with limitations of care that preclude full respiratory support. * Refusal of consent where consent is required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation. | From Baseline through Day 7 | 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. |
| Diaphragmatic Excursion Measured by Point of Care ultrasound | Baseline, 24 hours, 48 hours, and 72 hours | 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. |
| Diaphragmatic Thickness Measured by Point of Care Ultrasound | Baseline, 24 hours, 48 hours, and 72 hours | 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. |
| Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound | Baseline, 24 hours, 48 hours, and 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initiation of Invasive Mechanical Ventilation | From baseline through Day 7 | Time from study enrollment to initiation of invasive mechanical ventilation, measured in hours |
| Duration of invasive mechanical ventilation | 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. | Duration of invasive mechanical ventilation, calculated from the initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation, measured in days. |
| Number of Participants with Weaning failure | From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days. | 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. |
| Number of Participants With Extubation failure | within 72 hours after extubation. | Number of participants requiring reintubation and reinstitution of invasive mechanical ventilation following planned extubation. |
| Duration of Intensive Care Unit stay | From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days. | Duration of stay in the intensive care unit from ICU admission until ICU discharge, measured in days. |
| Number of Participants Who Die During Intensive Care Unit Stay | From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days. | Number of participants who die during the Intensive Care Unit stay |
Countries
Egypt
Contacts
CONTACTAbdallah Gamal Abd El Hafeez, Master
CONTACTDina Ali Ahmed, MD
STUDY_DIRECTORRefaat Fathy Abdelaal, professor
Assiut University
STUDY_DIRECTORDina Ali Ahmed, doctor
Assiut University
Outcome results
None listed