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Completed

NCT Number: NCT04680663

Predictor of Postoperative Complications After Lengthy Noncardiac Surgery

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.

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Key information

Conditions

Peripheral Perfusion Index

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo university

Cairo, 11451, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Peripheral Perfusion index

Diagnostic Test

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

serum lactate level

Diagnostic Test

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

Primary outcomes

  1. Peripheral perfusion index

    Time frame: up to 48 hours

    at end of surgery as early predictor of postoperative complications .

  2. serum lactate level

    Time frame: up do 48 hours

    at end of surgery as early predictor of postoperative complications .

Secondary outcomes

  1. serum lactate level

    Time frame: UP TO 30 day

    at end of surgery as early predictor of postoperative complications .

  2. Peripheral perfusion index

    Time frame: UP TO 30 DAY

    at end of surgery as predictor seversity of postoperative complications .

  3. Postoperative complications

    Time frame: up to 30 day

    the Clavien-Dindo classification system Grade I complications Grade II complications Grade III complications Grade IV complications

  4. hemodynamic change

    Time frame: up do 48 hours

    mean arterial blood pressure

  5. heart rate

    Time frame: up do 48 hours

    hemodynamic change

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: complication

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2020
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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