Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock (POCUS in RF)
Dynamic Point of Care Ultrasound (POCUS) Imaging Assessment of Diaphragmatic Function as a Predictor of Respiratory Failure and Clinical Outcomes in Patients With Septic Shock.
연구 개요
상태
상태
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Abdallah Gamal Abd El Hafeez, Master
- 전화번호: +0201221248314
- 이메일: abdallah.gamal0111@med.aun.edu.eg
연구 연락처 백업
- 이름: Dina Ali Ahmed, MD
- 전화번호: +0201063040703
- 이메일: dinaalihamad@aun.edu.eg
연구 장소
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Asyut, 이집트, 71515
- Faculty of medicine, Assiut university
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
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샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
기간: From Baseline through Day 7
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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.
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From Baseline through Day 7
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Diaphragmatic Excursion Measured by Point of Care ultrasound
기간: Baseline, 24 hours, 48 hours, and 72 hours
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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.
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Baseline, 24 hours, 48 hours, and 72 hours
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Diaphragmatic Thickness Measured by Point of Care Ultrasound
기간: Baseline, 24 hours, 48 hours, and 72 hours
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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.
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Baseline, 24 hours, 48 hours, and 72 hours
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Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound
기간: Baseline, 24 hours, 48 hours, and 72 hours
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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.
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Baseline, 24 hours, 48 hours, and 72 hours
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to Initiation of Invasive Mechanical Ventilation
기간: From baseline through Day 7
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Time from study enrollment to initiation of invasive mechanical ventilation, measured in hours
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From baseline through Day 7
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Duration of invasive mechanical ventilation
기간: 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.
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Duration of invasive mechanical ventilation, calculated from the initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation, measured in days.
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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.
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Number of Participants with Weaning failure
기간: From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.
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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.
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From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.
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Number of Participants With Extubation failure
기간: within 72 hours after extubation.
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Number of participants requiring reintubation and reinstitution of invasive mechanical ventilation following planned extubation.
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within 72 hours after extubation.
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Duration of Intensive Care Unit stay
기간: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
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Duration of stay in the intensive care unit from ICU admission until ICU discharge, measured in days.
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From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
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Number of Participants Who Die During Intensive Care Unit Stay
기간: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
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Number of participants who die during the Intensive Care Unit stay
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From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Refaat Fathy Abdelaal, professor, Assiut University
- 연구 책임자: Dina Ali Ahmed, doctor, Assiut University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
- 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.
- 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.
- 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.
- 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.
- Callahan LA, Supinski GS. Sepsis-induced myopathy. Crit Care Med. 2009 Oct;37(10 Suppl):S354-67. doi: 10.1097/CCM.0b013e3181b6e439.
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기타 연구 ID 번호
기타 연구 ID 번호
- POCUS in septic shock
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개별 참가자 데이터(IPD)를 공유할 계획입니까?
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