Predictor of Postoperative Complications After Lengthy Surgical Procedures

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Perfusion Index
• Intervention / Treatment: Diagnostic test: Peripheral Perfusion index; Diagnostic test: serum lactate level

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be designed to recruit patients scheduled for elective surgery with duration > 120 minutes under general anaesthesia

Description

• 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-III
• Patients scheduled for elective surgery under general anaesthesia .
• Exclusion criteria
• Refused to participate .
• ASA physical status of IV .
• 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 .
• Pregnancyor emergency surgery .
• shortening of the planned surgical time to be less than 120 minutes due to a surgical factor for example irrespectability or other causes .

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-severe complications group; where the non-complicated patients is the patients running the normal postoperative course of surgery and without any need for intervention	Diagnostic test: Peripheral Perfusion index; Peripheral Perfusion index is the ratio between pulsatile blood flow to non pulsatile blood flow or static blood in the peripheral tissue; Diagnostic test: serum 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
severe complications group; any deviation from the normal post-operative course	Diagnostic test: Peripheral Perfusion index; Peripheral Perfusion index is the ratio between pulsatile blood flow to non pulsatile blood flow or static blood in the peripheral tissue; Diagnostic test: serum 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum lactate level	at end of surgery as early predictor of postoperative complications .	UP TO 1 HOURE
Peripheral perfusion index	at end of surgery as early predictor of postoperative complications .	UP TO 1 HOURE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay	BY DAY	UP TO 30 DAY
hospital stay length	BY DAY	UP TO 30 DAY
duration of surgical time	MIN	UP TO 24 HOURE

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: MS-390-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No