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Predictor of Postoperative Complications After Lengthy Noncardiac Surgery

Peripheral Perfusion Index Versus Serum Lactate Levels as Predictor of Postoperative Complications and Prolonged ICU Stay After Lengthy Surgical Procedures: a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04680663
Acronym
complication
Enrollment
235
Registered
2020-12-23
Start date
2021-03-15
Completion date
2024-06-10
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Perfusion Index

Brief summary

Many patients undergoing long time surgery will manifest increased level of blood lactate. Hyperlactacidemia can cause disturbance of internal environment, then leading to increased complications and longer ICU stay, even death. For postoperative patients, we must ensure adequate perfusion in order to minimize the length of hyperglycemia and improve patients' outcomes. With regard to lactate, it provides information about prefusion, but not timely enough for its delay on reflecting hypoperfusion. And it's not real-time and non-invasive. Peripheral perfusion index (PPI) is an indicator reflecting hypoperfusion in critical patients. It is measured using pulse co-oximetry technology which is characterized by being real-time and noninvasive. PPI is defined as the ratio of pulsatile blood flow to the non-pulsatile blood flow, mirroring the strength of blood flow and quality of perfusion at sensor site, reflecting perfusion state of the body part . In contrast to lactate value, it's real-time and easy to monitor.

Interventions

Peripheral Perfusion index is the ratio between pulsatile blood flow to non pulsatile blood flow or static blood in the peripheral tissue

DIAGNOSTIC_TESTserum lactate level

Blood lactate (product of metabolism) level is maintained by a cycle of continuous production and metabolism allowing it to be kept within normal values

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Inclusion criteria * Adult patients above 18 years of age. * Both genders * surgical time planned to be \> 120 minutes . * surgical time predicted to exceed the planned time and prolongation of surgical time \> 120 minutes occured will be included in the study . * ASA physical status of I-II * Patients scheduled for elective surgery under general anaesthesia . *

Exclusion criteria

* Refused to participate . * patient with disease affecting blood flow to the hands where probe will be applied . * patient with hand injuries so probe cannot be applied * Patient with sever renal and liver disease * Discharging against medical advice or reported death during ICU stay at first 48 hours after ICU admission . * Pregnancy or emergency surgery . * shortening of the planned surgical time to be less than 120 minutes

Design outcomes

Primary

MeasureTime frameDescription
Peripheral perfusion indexup to 48 hoursat end of surgery as early predictor of postoperative complications .
serum lactate levelup do 48 hoursat end of surgery as early predictor of postoperative complications .

Secondary

MeasureTime frameDescription
Postoperative complicationsup to 30 daythe Clavien-Dindo classification system Grade I complications Grade II complications Grade III complications Grade IV complications
serum lactate levelUP TO 30 dayat end of surgery as early predictor of postoperative complications .
heart rateup do 48 hourshemodynamic change
hemodynamic changeup do 48 hoursmean arterial blood pressure
Peripheral perfusion indexUP TO 30 DAYat end of surgery as predictor seversity of postoperative complications .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026