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Assessment of Renal Perfusion Using Ultrasound and Near-Infrared Spectroscopy in Patients Undergoing Minimally Invasive Abdominal Surgery (RRI-NIRS)

3. juni 2026 oppdatert av: Lyudmila Martynenko Aydogdu, Istanbul University - Cerrahpasa

Prospective Observational Evaluation of Renal Perfusion Using Doppler Ultrasonography and Near-Infrared Spectroscopy in Patients Undergoing Elective Minimally Invasive Abdominal Surgery

This prospective observational study aims to evaluate renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion will be assessed using two non-invasive monitoring techniques: Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived renal regional oxygen saturation (rSO₂).

Measurements will be obtained at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period. Perioperative changes in renal perfusion parameters will be analyzed and correlated with clinical variables such as intra-abdominal pressure, pneumoperitoneum duration, hemodynamic parameters, fluid administration, urine output, and postoperative renal function.

The study also aims to investigate the relationship between intraoperative renal perfusion changes and the development of postoperative acute kidney injury. The findings may contribute to improved perioperative monitoring and optimization of renal perfusion during minimally invasive abdominal surgery.

Studieoversikt

Detaljert beskrivelse

Minimally invasive abdominal surgery has become increasingly common because of reduced surgical trauma, faster recovery, and lower postoperative morbidity compared with conventional open surgery. However, laparoscopic procedures require the creation of pneumoperitoneum, which may increase intra-abdominal pressure and adversely affect renal blood flow, renal oxygen delivery, and kidney function.

Renal hypoperfusion during surgery may contribute to postoperative renal dysfunction and acute kidney injury (AKI). Traditional indicators of renal injury, such as serum creatinine and urine output, often fail to detect early changes in renal perfusion. Therefore, reliable non-invasive methods for real-time assessment of renal perfusion are needed.

Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂) are promising techniques for evaluating renal perfusion and oxygenation. Both methods provide non-invasive, bedside assessment and may allow early detection of perfusion abnormalities before conventional markers become abnormal.

This prospective single-center observational study will evaluate perioperative renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion measurements will be obtained using Doppler ultrasonography and NIRS at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period.

Demographic characteristics, comorbidities, baseline renal function, intraoperative hemodynamic variables, pneumoperitoneum duration and pressure, fluid administration, urine output, blood loss, ventilatory parameters, and postoperative renal function will be recorded. Associations between perioperative renal perfusion parameters and postoperative renal outcomes, including acute kidney injury, will be investigated.

The findings of this study may improve understanding of perioperative renal perfusion changes during minimally invasive abdominal surgery and contribute to the development of strategies for optimizing renal protection and perioperative patient management

Studietype

Observasjonsmessig

Registrering (Antatt)

51

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Istanbul, Tyrkia (Türkiye), 34320
        • Rekruttering
        • Istanbul University Cerrahpasa Faculty of Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients aged 18-80 years with ASA physical status I-III undergoing elective minimally invasive abdominal surgery at Istanbul University-Cerrahpaşa Faculty of Medicine. Patients will be prospectively evaluated for perioperative renal perfusion using Doppler ultrasonography and Near-Infrared Spectroscopy (NIRS).

Beskrivelse

Inclusion Criteria:

  • Patients aged 18 to 80 years
  • Patients with ASA physical status I, II, or III
  • Patients undergoing elective minimally invasive abdominal surgery for any reason
  • Patients whose expected surgical duration is longer than 1 hour

Exclusion Criteria:

  • Body mass index greater than 35 kg/m²
  • Severe respiratory system disease
  • Severe heart failure, NYHA class III-IV
  • Presence of a cardiac pacemaker or cardiac defibrillator implant
  • Progressive neuromuscular disease
  • High intra-abdominal pressure
  • Sudden deterioration of general condition
  • Incomplete clinical or laboratory data
  • Refusal to participate in the study
  • Conversion to open surgery

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Elective Minimally Invasive Abdominal Surgery Patients
Adult patients aged 18 to 80 years undergoing elective minimally invasive abdominal surgery under general anesthesia. Renal perfusion will be assessed perioperatively and postoperatively(postoperative 1. hour) using Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂). Measurements will be performed at predefined perioperative time points and correlated with intraoperative variables, postoperative renal function, and the occurrence of acute kidney injury.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Renal Regional Oxygen Saturation Measured by NIRS
Tidsramme: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
Renal regional oxygen saturation (rSO₂) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS). NIRS values will be recorded at predefined perioperative time points.
after endotracheal intubation, immediately before extubation, and 1 hour after extubation
Change in Renal Resistive Index
Tidsramme: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
Renal Resistive Index (RRI) measured by Doppler ultrasonography at predefined perioperative time points. RRI will be calculated from peak systolic velocity and end-diastolic velocity obtained from renal interlobar or arcuate arteries.
after endotracheal intubation, immediately before extubation, and 1 hour after extubation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relationship Between Renal Resistive Index and Renal Regional Oxygen Saturation
Tidsramme: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
The relationship between renal Doppler ultrasonography-derived Renal Resistive Index (RRI) and NIRS-derived renal regional oxygen saturation (rSO₂) will be evaluated for the right and left kidneys at predefined perioperative measurement time points.
after endotracheal intubation, immediately before extubation, and 1 hour after extubation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. januar 2026

Primær fullføring (Antatt)

7. januar 2027

Studiet fullført (Antatt)

7. januar 2027

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared because the study was not designed with a data-sharing plan and participant confidentiality will be protected in accordance with institutional and ethical requirements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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