Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock

NCT07820267 | Not Yet Recruiting

• 1 other identifier: POCUS in septic shock
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration Failure; Diaphragmatic Dysfunction; Septic Shock; Mechanical Ventilation

Keywords

POCUS; septic shock; respiratory failure; diaphragm

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 24 hours, 48 hours, and 72 hours

Secondary Outcomes (6)

• Time to Initiation of Invasive Mechanical Ventilation

  From baseline through Day 7

• 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.

• 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 With Extubation failure

  within 72 hours after extubation.

• Duration of Intensive Care Unit stay

  From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.

Study Arms (2)

Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine, Assiut university

Asyut, 71515, Egypt

Location

Related Publications (15)

• Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682.

  PMID: 31876624 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.

  PMID: 28864053 BACKGROUND

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

  PMID: 24949192 BACKGROUND

• Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

  PMID: 19017880 BACKGROUND

• Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.

  PMID: 27620292 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.

  PMID: 28917004 BACKGROUND

• Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

  PMID: 26167730 BACKGROUND

• Powers SK, Wiggs MP, Sollanek KJ, Smuder AJ. Ventilator-induced diaphragm dysfunction: cause and effect. Am J Physiol Regul Integr Comp Physiol. 2013 Sep;305(5):R464-77. doi: 10.1152/ajpregu.00231.2013. Epub 2013 Jul 10.

  PMID: 23842681 BACKGROUND

• Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

  PMID: 18367735 BACKGROUND

• Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.

  PMID: 23786764 BACKGROUND

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

• Callahan LA, Supinski GS. Sepsis-induced myopathy. Crit Care Med. 2009 Oct;37(10 Suppl):S354-67. doi: 10.1097/CCM.0b013e3181b6e439.

  PMID: 20046121 BACKGROUND

• Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.

  PMID: 29937192 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Shock, Septic

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Refaat Fathy Abdelaal, professor

  Assiut University

  STUDY DIRECTOR

• Dina Ali Ahmed, doctor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abdallah Gamal Abd El Hafeez, Master

CONTACT

+0201221248314; abdallah.gamal0111@med.aun.edu.eg

Dina Ali Ahmed, MD

CONTACT

+0201063040703; dinaalihamad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Specialist

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)